Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria: Draft
Guidance for Industry |
2025-01-15 |
CBER |
Blood, Blood Products |
Draft |
Premarket Approval Application and
Humanitarian Device Exemption Modular
Review: Guidance for Industry and FDA Staff |
2025-01-13 |
CDRH; CBER |
Premarket, |
Final |
Accelerated Approval and Considerations for
Determining Whether a Confirmatory Trial is
Underway |
2025-01-07 |
OCE |
|
Draft |
Artificial Intelligence-Enabled Device
Software Functions: Lifecycle Management and
Marketing Submission Recommendations: Draft
Guidance for Industry and Food and Drug
Administration Staff |
2025-01-07 |
CDRH; CBER; CDER |
Postmarket, Premarket,
Digital Health |
Draft |
Considerations for Including Tissue Biopsies
in Clinical Trials |
2025-01-07 |
OCE |
|
Draft |
Considerations for the Use of Artificial
Intelligence To Support Regulatory
Decision-Making for Drug and Biological
Products: Draft Guidance for Industry and
Other Interested Parties |
2025-01-07 |
CVM; Office of
Inspections and
Investigations;
OCE; CBER; CDRH;
CDER; OC\Office of
the Chief Medical
Officer\OCP |
Artificial
Intelligence |
Draft |
CVM GFI #187B Heritable Intentional Genomic
Alterations in Animals: The Approval Process |
2025-01-07 |
CVM |
Premarket,
Biotechnology,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Final |
CVM GFI #251 - Heritable Intentional Genomic
Alterations in Animals of Food-Producing
Species for Use as Models of Disease |
2025-01-07 |
CVM |
Biotechnology,
Cellular & Gene
Therapy, Premarket,
Animal Cell-Based
Products |
Draft |
CVM GFI #260 - Type VII Veterinary Master
File for Research and Development and Risk
Reviews |
2025-01-07 |
CVM |
Biotechnology,
Cellular & Gene
Therapy, Animal
Cell-Based Products |
Draft |
CVM GFI #294 - Animal Food Ingredient
Consultation (AFIC) |
2025-01-07 |
CVM |
Premarket, Animal Food
Additives, Labeling,
Safety - Issues,
Errors, and Problems |
Final |
| Developing Drugs for Optical Imaging |
2025-01-07 |
CDRH; CDER |
Clinical - Medical |
Draft |
Evaluation of Sex-Specific and
Gender-Specific Data in Medical Device
Clinical Studies: Draft Guidance for
Industry and Food and Drug Administration
Staff |
2025-01-07 |
CDRH; CBER |
Premarket, Postmarket,
Good Clinical Practice
(GCP) |
Draft |
Notifying FDA of a Permanent Discontinuance
or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act:
Guidance for Industry and Food and Drug
Administration Staff |
2025-01-07 |
CDRH; CBER |
Postmarket, |
Final |
Obesity and Overweight: Developing Drugs and
Biological Products for Weight Reduction |
2025-01-07 |
CDER |
Clinical - Medical |
Draft |
Pulse Oximeters for Medical Purposes -
Non-Clinical and Clinical Performance
Testing, Labeling, and Premarket Submission
Recommendations: Draft Guidance for Industry
and Food and Drug Administration Staff |
2025-01-07 |
CDRH |
Premarket, |
Draft |
Communications From Firms to Health Care
Providers Regarding Scientific Information
on Unapproved Uses of Approved/Cleared
Medical Products: Questions and Answers |
2025-01-06 |
CVM; CBER; CDRH;
CDER; OC |
Administrative /
Procedural |
Final |
Considerations for Complying with 21 CFR
211.110 |
2025-01-06 |
CDER; CBER; CVM |
Current Good
Manufacturing Practice
(CGMP), Pharmaceutical
Quality |
Draft |
Draft Guidance for Industry: Establishing
Sanitation Programs for Low-Moisture
Ready-to-Eat Human Foods and Taking
Corrective Actions Following a Pathogen
Contamination Event |
2025-01-06 |
Human Foods
Program |
|
Draft |
Draft Guidance for Industry: Labeling of
Plant-Based Alternatives to Animal-Derived
Foods |
2025-01-06 |
Human Foods
Program |
Labeling |
Draft |
Guidance for FDA Staff and Interested
Parties: Evaluating the Public Health
Importance of Food Allergens Other Than the
Major Food Allergens Listed in the Federal
Food, Drug, and Cosmetic Act |
2025-01-06 |
Human Foods
Program |
Allergens, Labeling |
Final |
Guidance for Industry: Action Levels for
Lead in Processed Food Intended for Babies
and Young Children |
2025-01-06 |
Human Foods
Program |
Infant Formula &
Foods, Lead |
Final |
Guidance for Industry: Questions and Answers
Regarding Food Allergen Labeling (Edition 5) |
2025-01-06 |
Human Foods
Program |
Allergens, Labeling |
Final |
Interim Policy on Compounding Using Bulk
Drug Substances Under Section 503A of the
Federal Food, Drug, and Cosmetic Act |
2025-01-06 |
CDER |
Administrative /
Procedural,
Compounding |
Final |
Interim Policy on Compounding Using Bulk
Drug Substances Under Section 503B of the
Federal Food, Drug, and Cosmetic Act |
2025-01-06 |
CDER |
Administrative /
Procedural,
Compounding |
Final |
Recommendations for Determining Eligibility
of Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps):
Draft Guidance for Industry |
2025-01-06 |
CBER |
Tissue |
Draft |
Recommendations to Reduce the Risk of
Transmission of Disease Agents Associated
with Sepsis by Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps):
Guidance for Industry |
2025-01-06 |
CBER |
Tissue |
Final |
Recommendations to Reduce the Risk of
Transmission of Hepatitis B Virus (HBV) by
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps): Draft
Guidance for Industry |
2025-01-06 |
CBER |
Hepatitis B, Tissue |
Draft |
Recommendations to Reduce the Risk of
Transmission of Hepatitis C Virus (HCV) by
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps): Draft
Guidance for Industry |
2025-01-06 |
CBER |
Hepatitis C, Tissue |
Draft |
Recommendations to Reduce the Risk of
Transmission of Human Immunodeficiency Virus
(HIV) by Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps): Draft
Guidance for Industry |
2025-01-06 |
CBER |
HIV/AIDS, Tissue |
Draft |
Recommendations to Reduce the Risk of
Transmission of Mycobacterium tuberculosis
(Mtb) by Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps):
Guidance for Industry |
2025-01-06 |
CBER |
Tuberculosis, Tissue |
Final |
Study of Sex Differences in the Clinical
Evaluation of Medical Products |
2025-01-06 |
CBER; CDRH; CDER |
Clinical - Medical |
Draft |
Validation and Verification of Analytical
Testing Methods Used for Tobacco Products |
2025-01-06 |
CTP |
|
Final |
Validation of Certain In Vitro Diagnostic
Devices for Emerging Pathogens During a
Section 564 Declared Emergency: Draft
Guidance for Industry and Food and Drug
Administration Staff |
2025-01-06 |
CDRH\Office of
Product Evaluation
and Quality\Office
of In Vitro
Diagnostics and
Radiological
Health |
IVDs (In Vitro
Diagnostic Devices) |
Draft |
Advanced Manufacturing Technologies
Designation Program |
2024-12-31 |
CBER; CDER |
Chemistry,
Manufacturing, and
Controls (CMC),
Pharmaceutical Quality |
Final |
| E11A Pediatric Extrapolation |
2024-12-30 |
CDER; CBER |
ICH-Efficacy,
Pediatric Product
Development |
Final |
| E6(R3) Good Clinical Practice: Annex 2 |
2024-12-30 |
CDER |
ICH-Efficacy |
Draft |
M15 General Principles for Model-Informed
Drug Development |
2024-12-30 |
CDER; CBER |
ICH-Multidisciplinary |
Draft |
Protocol Deviations for Clinical
Investigations of Drugs, Biological
Products, and Devices |
2024-12-30 |
CDER; CBER; CDRH;
OCE |
Clinical - Medical |
Draft |
Combined Food and Drug Administration and
Sponsor Oncologic Drugs Advisory Committee
Briefing Document |
2024-12-27 |
OCE |
Prescription Drugs,
Oncology |
Draft |
Global Unique Device Identification Database
(GUDID): Guidance for Industry and Food and
Drug Administration Staff |
2024-12-17 |
CDRH |
GUDID, Labeling, UDI |
Final |
Technical Specifications for Submitting
Clinical Trial Data Sets for Treatment of
Noncirrhotic Nonalcoholic Steatohepatitis
(NASH): Guidance for Industry Technical
Specifications Document |
2024-12-13 |
CDER |
|
Final |
Guidance for Industry: Registration and
Listing of Cosmetic Product Facilities and
Products |
2024-12-11 |
OC\Office of the
Chief Scientist |
|
Final |
Standardized Format for Electronic
Submission of NDA and BLA Content for the
Planning of Bioresearch Monitoring (BIMO)
Inspections for CDER Submissions Guidance
for Industry |
2024-12-06 |
CDER |
Electronic
Submissions, |
Final |
Accelerated Approval – Expedited Program
for Serious Conditions |
2024-12-05 |
CDER |
|
Draft |
CVM GFI #49 Evaluating Target Animal Safety
and Effectiveness of Antibacterial New
Animal Drugs for Bovine Mastitis |
2024-12-04 |
CVM |
Premarket, Animal
Drugs, Clinical -
Antimicrobial, Target
Animal –
Effectiveness, Target
Animal – Safety,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Draft |
Marketing Submission Recommendations for a
Predetermined Change Control Plan for
Artificial Intelligence-Enabled Device
Software Functions: Guidance for Industry
and Food and Drug Administration Staff |
2024-12-04 |
CDRH; CBER; CDER;
OC\OCPP\OCP |
Premarket, Digital
Health |
Final |
Draft Guidance for Industry: Notifying FDA
of a Permanent Discontinuance in the
Manufacture or an Interruption of the
Manufacture of an Infant Formula |
2024-12-02 |
Human Foods
Program |
Infant Formula & Foods |
Draft |
Recommended Followup Testing for an
Ames-Positive Drug (Active Ingredient) or
Metabolite To Support First-in-Human
Clinical Trials With Healthy Subjects |
2024-11-27 |
CDER |
Pharmacology/Toxicology |
Draft |
Use of Circulating Tumor Deoxyribonucleic
Acid for Early-Stage Solid Tumor Drug
Development; Guidance for Industry;
Availability |
2024-11-27 |
OCE |
|
Final |
Assessment of Ovarian Toxicity in
Premenopausal Adults During Drug Development
for Oncologic Products |
2024-11-26 |
OCE; CDER; CBER |
|
Draft |
Transitional Enforcement Policy for Ethylene
Oxide Sterilization Facility Changes for
Class III Devices: Guidance for Industry
and Food and Drug Administration Staff |
2024-11-26 |
CDRH |
Premarket Approval
(PMA), HUD/HDE |
Final |
Orthopedic Non-Spinal Bone Plates, Screws,
and Washers - Premarket Notification
(510(k)) Submissions: Guidance for Industry
and Food and Drug Administration Staff |
2024-11-22 |
CDRH\Office of
Product Evaluation
and Quality\Office
of Health
Technology VI -
Orthopedic Devices |
Premarket, 510(k),
Orthopedic |
Final |
Orthopedic Non-Spinal Metallic Bone Screws
and Washers - Performance Criteria for
Safety and Performance Based Pathway:
Guidance for Industry and Food and Drug
Administration Staff |
2024-11-22 |
CDRH |
Premarket, 510(k),
Orthopedic |
Final |
510(k) Third Party Review Program and Third
Party Emergency Use Authorization (EUA)
Review: Guidance for Industry, Food and
Drug Administration Staff, and Third Party
Review Organizations |
2024-11-21 |
CDRH |
Premarket, 510(k),
Administrative /
Procedural |
Final |
Frequently Asked Questions — Developing
Potential Cellular and Gene Therapy Products |
2024-11-18 |
CBER |
Gene Therapy,
Pediatric Product
Development |
Draft |
Nonclinical Safety Assessment of
Oligonucleotide-Based Therapeutics |
2024-11-15 |
CDER |
Pharmacology/Toxicology |
Draft |
Guidance for Industry: FDA's Voluntary
Qualified Importer Program |
2024-11-14 |
CVM; Office of
Inspections and
Investigations;
Human Foods
Program |
Import |
Final |
CPG Sec 540.525 Scombrotoxin
(Histamine)-forming Fish and Fishery
Products – Decomposition and Histamine
(CPG 7108.24) |
2024-11-01 |
Human Foods
Program; Office of
Inspections and
Investigations |
Investigation &
Enforcement,
Seafood/Seafood
Product |
Final |
Study Data Technical Conformance Guide -
Technical Specifications Document |
2024-10-31 |
CDER |
|
Final |
M13A Bioequivalence for Immediate-Release
Solid Oral Dosage Forms |
2024-10-30 |
CDER |
ICH-Multidisciplinary |
Final |
CVM GFI #293 - FDA Enforcement Policy for
AAFCO-Defined Animal Feed Ingredients |
2024-10-24 |
CVM |
Postmarket, Premarket,
Animal Food Additives,
Labeling |
Final |
Guidance for Industry: Insanitary Conditions
in the Preparation, Packing, and Holding of
Tattoo Inks and the Risk of Microbial
Contamination |
2024-10-22 |
OC\Office of the
Chief Scientist |
Tattoos |
Final |
Drug Interaction Information in Human
Prescription Drug and Biological Product
Labeling |
2024-10-21 |
CDER |
Labeling, Clinical -
Pharmacology |
Draft |
Considerations for Long-Term Clinical
Neurodevelopmental Safety Studies in
Neonatal Product Development: Guidance for
Industry |
2024-10-17 |
CBER; CDRH; CDER;
OC\Office of the
Chief Medical
Officer\OPT |
Clinical - Medical,
Pediatric Product
Development |
Final |
Core Patient-Reported Outcomes in Cancer
Clinical Trials: Guidance for Industry |
2024-10-17 |
OCE; CBER; CDER |
Clinical Trials,
Clinical - Medical |
Final |
Postoperative Nausea and Vomiting:
Developing Drugs for Prevention |
2024-10-17 |
CDER |
Clinical - Medical |
Draft |
Recommendations for the Development of Blood
Collection, Processing, and Storage Systems
for the Manufacture of Blood Components
Using the Buffy Coat Method |
2024-10-17 |
CBER |
Blood, Blood Products |
Draft |
Review of Drug Master Files in Advance of
Certain ANDA Submissions Under GDUFA |
2024-10-17 |
CDER |
User Fees, Chemistry,
Manufacturing, and
Controls (CMC),
Generic Drugs,
Pharmaceutical
Quality, Drug
Competition Action
Plan |
Final |
Requests for Reconsideration at the Division
Level Under GDUFA |
2024-10-16 |
CDER |
User Fees, Generic
Drugs |
Final |
CVM GFI #284 Using Relative Supersaturation
to Support “Urinary Tract Health” Claims
for Adult Maintenance Cat Food |
2024-10-15 |
CVM |
Animal Feed, Labeling |
Final |
Endosseous Dental Implants and Endosseous
Dental Implant Abutments - Performance
Criteria for Safety and Performance Based
Pathway: Guidance for Industry and Food and
Drug Administration Staff |
2024-10-15 |
CDRH |
Premarket, 510(k),
Dental |
Final |
Temporary Policies for Compounding Certain
Parenteral Drug Products: Guidance for
Industry |
2024-10-11 |
CDER |
Compounding |
Final |
Electronic Systems, Electronic Records, and
Electronic Signatures in Clinical
Investigations: Questions and Answers |
2024-10-01 |
CDER; OC\OCPP |
Administrative /
Procedural |
Final |
Air Powered Dental Handpieces and Air Motors
- Performance Criteria for Safety and
Performance Based Pathway: Guidance for
Industry and Food and Drug Administration
Staff |
2024-09-30 |
CDRH |
Premarket, 510(k),
Dental |
Final |
CVM GFI #116 (VICH GL23 (R2)) Studies to
Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Genotoxicity
Testing (Revision 2) |
2024-09-30 |
CVM |
Human Food Safety,
VICH |
Draft |
Dental Cements - Performance Criteria for
Safety and Performance Based Pathway:
Guidance for Industry and Food and Drug
Administration Staff |
2024-09-30 |
CDRH |
Premarket, 510(k),
Dental |
Final |
Dental Ceramics - Performance Criteria for
Safety and Performance Based Pathway:
Guidance for Industry and Food and Drug
Administration Staff |
2024-09-30 |
CDRH |
Premarket, 510(k),
Dental |
Final |
Dental Impression Materials - Performance
Criteria for Safety and Performance Based
Pathway: Guidance for Industry and Food and
Drug Administration Staff |
2024-09-30 |
CDRH |
Premarket, 510(k),
Dental |
Final |
Clarification of Radiation Control
Regulations For Manufacturers of Diagnostic
X-Ray Equipment: Guidance for Industry and
Food and Drug Administration Staff |
2024-09-27 |
CDRH\Office of
Product Evaluation
and Quality\Office
of In Vitro
Diagnostics and
Radiological
Health |
Export, Import,
Labeling, Radiology |
Final |
Clinical Pharmacology Considerations for
Human Radiolabeled Mass Balance Studies |
2024-09-26 |
CDER |
Clinical -
Pharmacology |
Final |
An Acceptable Circular of Information for
the Use of Human Blood and Blood Components:
Guidance for Industry |
2024-09-25 |
CBER |
Blood, Blood Products |
Final |
Small Entity Compliance Guide: Standards for
the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption |
2024-09-25 |
Human Foods
Program |
Produce |
Final |
Basic Safety and Essential Performance of
Medical Electrical Equipment, Medical
Electrical Systems, and Laboratory Medical
Equipment - Standards Specific Information
for the Accreditation Scheme for Conformity
Assessment (ASCA) Program: Draft Guidance
for Industry, Accreditation Bodies, Testing
Laboratories, and Food and Drug
Administration Staff |
2024-09-23 |
CDRH; CBER |
Premarket, |
Draft |
Biocompatibility Testing of Medical Devices
- Standards Specific Information for the
Accreditation Scheme for Conformity
Assessment (ASCA) Program : Draft Guidance
for Industry, Accreditation Bodies, Testing
Laboratories, and Food and Drug
Administration Staff |
2024-09-23 |
CDRH; CBER |
Premarket, |
Draft |
The Accreditation Scheme for Conformity
Assessment (ASCA) Program: Draft Guidance
for Industry, Accreditation Bodies, Testing
Laboratories, and Food and Drug
Administration Staff |
2024-09-23 |
CDRH; CBER |
Premarket, |
Draft |
Chemical Analysis for Biocompatibility
Assessment of Medical Devices: Draft
Guidance for Industry and Food and Drug
Administration Staff |
2024-09-20 |
CDRH; CBER |
Premarket, Chemistry,
Manufacturing, and
Controls (CMC) |
Draft |
Conducting Clinical Trials With
Decentralized Elements |
2024-09-18 |
CDER; CBER; CDRH;
OCE |
Clinical - Medical |
Final |
Integrating Randomized Controlled Trials for
Drug and Biological Products Into Routine
Clinical Practice: Draft Guidance for
Industry |
2024-09-18 |
CDER; CBER; OCE |
Real World Data / Real
World Evidence
(RWD/RWE), |
Draft |
CVM GFI #227 Chemistry, Manufacturing, and
Controls (CMC) Technical Section Filing
Strategies |
2024-09-17 |
CVM |
Premarket, Animal
Drugs, Chemistry,
Manufacturing, and
Controls (CMC),
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Draft |
Considerations for Generating Clinical
Evidence from Oncology Multiregional
Clinical Development Programs |
2024-09-16 |
OCE |
Clinical - Medical |
Draft |
| Data Standards Catalog |
2024-09-16 |
CBER; CDRH; CDER;
Human Foods
Program; CVM |
|
Final |
Enforcement Policy for Required Warnings for
Cigarette Packages and Advertisements |
2024-09-13 |
CTP |
|
Final |
Providing Regulatory Submissions in
Electronic Format — Certain Human
Pharmaceutical Product Applications and
Related Submissions Using the eCTD
Specifications Guidance for Industry |
2024-09-13 |
CDER; CBER |
Electronic
Submissions, |
Final |
Required Warnings for Cigarette Packages and
Advertisements: Small Entity Compliance
Guide (Revised): Guidance for Industry |
2024-09-12 |
CTP |
|
Final |
Submission of Plans for Cigarette Packages
and Cigarette Advertisements (Revised) |
2024-09-12 |
CTP |
|
Final |
ANDA Submissions | Amendments to Abbreviated
New Drug Applications Under GDUFA: Guidance
for Industry |
2024-09-11 |
CDER |
User Fees, Drug
Competition Action
Plan, Generic Drugs |
Final |
Appeal Options Available to Mammography
Facilities Concerning Adverse Accreditation
Decisions, Suspension/Revocation of
Certificates, or Patient and Referring
Provider Notification Orders: Guidance for
Mammography Facilities and Food and Drug
Administration Staff |
2024-09-10 |
CDRH |
Investigation &
Enforcement,
Administrative /
Procedural,
Radiological Health,
Radiology |
Final |
Incorporating Voluntary Patient Preference
Information over the Total Product Life
Cycle: Draft Guidance for Industry, Food and
Drug Administration Staff, and Other
Interested Parties |
2024-09-06 |
CDRH; CBER |
|
Draft |
| Withdrawn Guidances (Biologics) |
2024-09-06 |
CBER |
|
Final |
Control of Nitrosamine Impurities in Human
Drugs: Guidance for Industry |
2024-09-05 |
CDER |
Current Good
Manufacturing Practice
(CGMP), Pharmaceutical
Quality |
Final |
Bioresearch Monitoring Technical Conformance
Guide |
2024-09-03 |
CDER |
Electronic
Submissions, |
Final |
Voluntary Malfunction Summary Reporting
(VMSR) Program for Manufacturers: Guidance
for Industry and Food and Drug
Administration Staff |
2024-08-29 |
CBER; CDRH |
|
Final |
CVM GFI #63 (VICH GL1) Validation of
Analytical Procedures: Definition and
Terminology |
2024-08-28 |
CVM |
Chemistry,
Manufacturing, and
Controls (CMC), VICH |
Final |
CVM GFI #64 (VICH GL2) Validation of
Analytical Procedures: Methodology |
2024-08-28 |
CVM |
Chemistry,
Manufacturing, and
Controls (CMC), VICH |
Final |
Mammography Quality Standards Act and
Regulation Amendments: Small Entity
Compliance Guide: Guidance for Industry and
Food and Drug Administration Staff |
2024-08-26 |
CDRH |
|
Final |
Electronic Submission Template for Medical
Device De Novo Requests: Guidance for
Industry and Food and Drug Administration
Staff |
2024-08-23 |
CBER; CDRH |
Premarket, Electronic
Submissions, |
Final |
FDA and Industry Procedures for Section
513(g) Requests for Information under the
Federal Food, Drug, and Cosmetic Act:
Guidance for Industry and Food and Drug
Administration Staff |
2024-08-23 |
CBER; CDRH |
Premarket,
Administrative /
Procedural, Labeling |
Final |
Predetermined Change Control Plans for
Medical Devices: Draft Guidance for Industry
and FDA Staff |
2024-08-22 |
CDRH; CBER |
Premarket, |
Draft |
Product-Specific Guidance Meetings Between
FDA and ANDA Applicants Under GDUFA:
Guidance for Industry |
2024-08-20 |
CDER\OGD |
Drug Competition
Action Plan, Generic
Drugs |
Final |
Acceptable Media for Electronic Product User
Manuals: Guidance for Industry and FDA
Staff |
2024-08-19 |
CDRH |
|
Final |
Draft Guidance for Industry: Voluntary
Sodium Reduction Goals (Edition 2) |
2024-08-15 |
Human Foods
Program |
|
Draft |
Bacillus Calmette-Guérin-Unresponsive
Nonmuscle Invasive Bladder Cancer:
Developing Drugs and Biological Products for
Treatment : Draft Guidance for Industry |
2024-08-08 |
CDER; CBER |
Clinical - Medical |
Draft |
Optimizing the Dosage of Human Prescription
Drugs and Biological Products for the
Treatment of Oncologic Diseases: Guidance
for Industry; Availability |
2024-08-08 |
OCE; CDER; CBER |
|
Final |
| M12 Drug Interaction Studies |
2024-08-02 |
CDER\ORP; CBER |
ICH-Multidisciplinary |
Final |
M12 Drug Interaction Studies: Questions and
Answers |
2024-08-02 |
CDER; CBER |
ICH-Multidisciplinary |
Final |
FDA Regional Implementation Guide for
E2B(R3) Electronic Transmission of
Individual Case Safety Reports for Drug and
Biological Products |
2024-08-01 |
CDER |
ICH-Safety |
Final |
CVM GFI #100 (VICH GL18 (R2)) Impurities:
Residual Solvents in New Veterinary
Medicinal Products, Active Substances and
Excipients (Revision 2) |
2024-07-25 |
CVM |
Chemistry,
Manufacturing, and
Controls (CMC), VICH |
Final |
Providing Over-the-Counter Monograph
Submissions in Electronic Format |
2024-07-25 |
CDER |
Electronic
Submissions, |
Final |
Real-World Data: Assessing Electronic Health
Records and Medical Claims Data To Support
Regulatory Decision-Making for Drug and
Biological Products: Guidance for Industry |
2024-07-25 |
CDER; CBER; OCE |
Real World Data / Real
World Evidence
(RWD/RWE), |
Final |
Container Closure System and Component
Changes: Glass Vials and Stoppers |
2024-07-24 |
CDER; CBER |
|
Final |
Postapproval Manufacturing Changes to
Biosimilar and Interchangeable Biosimilar
Products Questions and Answers |
2024-07-23 |
CDER; CBER |
Current Good
Manufacturing Practice
(CGMP) |
Draft |
Pediatric Inflammatory Bowel Disease:
Developing Drugs for Treatment |
2024-07-19 |
CDER |
Clinical - Medical,
Pediatric Product
Development |
Draft |
Recommendations for Investigational and
Licensed COVID-19 Convalescent Plasma:
Guidance for Industry |
2024-07-19 |
CBER |
Blood, Infectious
Disease Treatment,
Coronavirus, Blood
Products |
Final |
Blood Pressure and Pulse Donor Eligibility
Requirements – Compliance Policy:
Guidance for Industry |
2024-07-17 |
CBER |
Blood, Blood Products |
Final |
Application User Fees for Combination
Products: Guidance for Industry and FDA
Staff |
2024-07-16 |
OC\OCPP\OCP |
User Fees, Combination
Products, Pediatric
Product Development |
Final |
Drugs for the Treatment of Partial Onset
Seizures: Extrapolation of Efficacy from
Adults to Pediatric Patients 1 Month of Age
and Older |
2024-07-15 |
CDER |
Clinical -
Pharmacology,
Pediatric Product
Development |
Final |
Dental Composite Resin Devices - Premarket
Notification (510(k)) Submissions: Draft
Guidance for Industry and Food and Drug
Administration Staff |
2024-07-12 |
CDRH |
Premarket, 510(k),
Dental |
Draft |
Dental Curing Lights - Premarket
Notification (510(k)) Submissions: Draft
Guidance for Industry and Food and Drug
Administration Staff |
2024-07-12 |
CDRH |
Premarket, 510(k),
Dental |
Draft |
Clinical Considerations for Studies of
Devices Intended to Treat Opioid Use
Disorder: Guidance for Industry and Food
and Drug Administration Staff |
2024-07-11 |
CDRH |
|
Final |
Addressing Misinformation About Medical
Devices and Prescription Drugs: Questions
and Answers |
2024-07-08 |
CVM; CBER; CDRH;
CDER |
Advertising |
Draft |
Purpose and Content of Use-Related Risk
Analyses for Drugs, Biological Products, and
Combination Products |
2024-07-08 |
CBER; CDRH; CDER;
OC\OCPP\OCP |
|
Draft |
M14 General Principles on Plan, Design, and
Analysis of Pharmacoepidemiological Studies
That Utilize Real-World Data for Safety
Assessment of Medicines |
2024-07-05 |
CDER; CBER |
ICH-Multidisciplinary |
Draft |
Essential Drug Delivery Outputs for Devices
Intended to Deliver Drugs and Biological
Products: Draft Guidance for Industry |
2024-06-28 |
OC\OCPP\OCP; CBER;
CDRH; CDER |
Combination Products,
Pediatric Product
Development |
Draft |
CVM GFI #276 Effectiveness of Anthelmintics:
Specific Recommendations for Products
Proposed for the Prevention of Heartworm
Disease in Dogs |
2024-06-26 |
CVM |
Premarket,
Anthelmintics,
Investigational New
Animal Drug (INAD),
Target Animal –
Effectiveness |
Final |
CVM GFI #283 Priority Zoonotic Animal Drug
Designation and Review Process |
2024-06-26 |
CVM |
Premarket, Animal
Drugs, Investigational
New Animal Drug
(INAD), New Animal
Drug Application
(NADA) |
Final |
Diversity Action Plans to Improve Enrollment
of Participants from Underrepresented
Populations in Clinical Studies: Draft
Guidance for Industry |
2024-06-26 |
OCE; CBER; CDER;
CDRH; OC\Office of
Minority Health
and Health Equity;
OC\Office of
Women's Health |
Pediatric Product
Development |
Draft |
Laboratory Developed Tests: Small Entity
Compliance Guide: Guidance for Laboratory
Manufacturers and Food and Drug
Administration Staff |
2024-06-25 |
CDRH; CBER |
IVDs (In Vitro
Diagnostic Devices) |
Final |
CVM GFI #288 Chemistry, Manufacturing, and
Controls in Support of Recombinant Protein
Products for Veterinary Medicinal Use |
2024-06-24 |
CVM |
Premarket,
Biotechnology,
Chemistry,
Manufacturing, and
Controls (CMC),
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Draft |
CVM GFI #292 Chemistry, Manufacturing, and
Controls Considerations for Type A Medicated
Articles |
2024-06-24 |
CVM |
Premarket, Chemistry,
Manufacturing, and
Controls (CMC),
Current Good
Manufacturing Practice
(CGMP), Generic Animal
Drugs, Investigational
New Animal Drug
(INAD), New Animal
Drug Application
(NADA) |
Draft |
Considerations in Demonstrating
Interchangeability With a Reference Product:
Update |
2024-06-21 |
CDER; CBER |
Biosimilars |
Draft |
CVM GFI #278 Human User Safety in New and
Abbreviated New Animal Drug Applications |
2024-06-21 |
CVM |
Premarket, Animal
Drugs, Investigational
New Animal Drug
(INAD), New Animal
Drug Application
(NADA), Labeling,
Safety - Issues,
Errors, and Problems,
Pharmacology/Toxicology |
Final |
CVM GFI #279 Demonstrating Bioequivalence
for Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s)
Considered to be Poorly Soluble in Aqueous
Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting |
2024-06-21 |
CVM |
Premarket, Generic
Animal Drugs,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Final |
Circumstances that Constitute Delaying,
Denying, Limiting, or Refusing a Drug or
Device Inspection: Guidance for Industry |
2024-06-20 |
Office of
Inspections and
Investigations;
CDER; CBER; CVM;
CDRH |
Postmarket,
Investigation &
Enforcement, |
Final |
Facility Readiness: Goal Date Decisions
Under GDUFA |
2024-06-18 |
CDER |
Generic Drugs |
Final |
Diabetic Foot Infections: Developing Drugs
for Treatment |
2024-06-17 |
CDER |
Clinical -
Antimicrobial |
Final |
Clinical Pharmacology Considerations for the
Development of Oligonucleotide Therapeutics:
Guidance for Industry |
2024-06-14 |
CDER |
Clinical -
Pharmacology |
Final |
Processes and Practices Applicable to
Bioresearch Monitoring Inspections: Draft
Guidance for Industry |
2024-06-05 |
Office of
Inspections and
Investigations;
OC\OCPP; CBER;
CDER; CDRH; Human
Foods Program;
CTP; CVM |
Clinical Trials,
Compliance,
Postmarket, Premarket,
Investigation &
Enforcement,
Inspection,
International,
Administrative /
Procedural,
Bioequivalence,
Biopharmaceutics,
Biosimilars,
Investigational New
Drug Application
(INDA), Food & Color
Additives, Generic
Drugs, HUD/HDE,
Investigational Device
Exemption (IDE),
Premarket Approval
(PMA), IVDs (In Vitro
Diagnostic Devices),
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA),
Vaccines |
Draft |
Standardized Format for Electronic
Submission for Marketing Applications
Content for the Planning of Bioresearch
Monitoring (BIMO) Inspections for Center of
Biologics Evaluation and Research
Submissions |
2024-06-05 |
CBER |
Electronic
Submissions, |
Draft |
Platform Technology Designation Program for
Drug Development |
2024-05-28 |
CDER; CBER |
|
Draft |
CVM GFI #115 (VICH GL22) Studies to Evaluate
the Safety of Residues of Veterinary Drugs
in Human Food: Reproduction Toxicity Testing
(Revision 1) |
2024-05-23 |
CVM |
Human Food Safety,
VICH |
Draft |
Remanufacturing of Medical Devices:
Guidance for Industry, Entities That Perform
Servicing or Remanufacturing, and Food and
Drug Administration Staff |
2024-05-10 |
CDRH; CBER |
Labeling |
Final |
REMS Logic Model: A Framework to Link
Program Design With Assessment |
2024-05-07 |
CDER; CBER |
Safety - Issues,
Errors, and Problems |
Draft |
Consideration of Enforcement Policies for
Tests During a Section 564 Declared
Emergency: Draft Guidance for Industry and
Food and Drug Administration Staff |
2024-05-06 |
CDRH |
Outbreak, IVDs (In
Vitro Diagnostic
Devices) |
Draft |
CVM GFI #290 (VICH GL61) – Pharmaceutical
Development |
2024-05-06 |
CVM |
Premarket, Postmarket,
Chemistry,
Manufacturing, and
Controls (CMC),
Quality, Generic
Animal Drugs,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA),
VICH |
Draft |
Enforcement Policy for Certain In Vitro
Diagnostic Devices for Immediate Public
Health Response in the Absence of a
Declaration under Section 564: Draft
Guidance for Laboratory Manufacturers and
Food and Drug Administration Staff |
2024-05-06 |
CDRH |
Outbreak, IVDs (In
Vitro Diagnostic
Devices) |
Draft |
CVM GFI #187A Heritable Intentional Genomic
Alterations in Animals: Risk-Based Approach |
2024-05-02 |
CVM |
Biotechnology, |
Final |
Recognition and Use of a Standard for
Uniform Blood and Blood Component Container
Labels: Guidance for Industry |
2024-04-30 |
CBER |
Blood Products |
Final |
Considerations for the Use of Human-and
Animal-Derived Materials in the Manufacture
of Cell and Gene Therapy and
Tissue-Engineered Medical Products |
2024-04-29 |
CBER |
Gene Therapy, Tissue,
Xenotransplantation |
Draft |
Content and Format of Composition Statement
and Corresponding Statement of Ingredients
in Labeling in NDAs and ANDAs |
2024-04-29 |
CDER |
Electronic
Submissions, Drug
Competition Action
Plan, Generic Drugs |
Draft |
CVM GFI #120 Veterinary Feed Directive
Regulation Questions and Answers |
2024-04-29 |
CVM |
Animal Feed |
Final |
CVM GFI #287 - Raw Data for Safety and
Effectiveness Studies |
2024-04-29 |
CVM |
Premarket,
Environmental Safety,
Human Food Safety,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA),
Target Animal –
Effectiveness, Target
Animal – Safety |
Draft |
Safety Testing of Human Allogeneic Cells
Expanded for Use in Cell-Based Medical
Products |
2024-04-29 |
CBER |
Gene Therapy |
Draft |
Small Entity Compliance Guide: Revocation of
Uses of Partially Hydrogenated Oils in Foods |
2024-04-29 |
Human Foods
Program |
|
Final |
Cancer Clinical Trial Eligibility Criteria:
Laboratory Values: Draft Guidance for
Industry, IRBs, and Clinical Investigators |
2024-04-25 |
OCE; CDER; CBER |
Clinical Trials, |
Draft |
Cancer Clinical Trial Eligibility Criteria:
Performance Status: Draft Guidance for
Industry, IRBs, and Clinical Investigators |
2024-04-25 |
OCE; CDER; CBER |
Clinical Trials, |
Draft |
Cancer Clinical Trial Eligibility Criteria:
Washout Periods and Concomitant Medications:
Draft Guidance for Industry, IRBs, and
Clinical Investigators |
2024-04-25 |
OCE; CDER; CBER |
Clinical Trials, |
Draft |
Promotional Labeling and Advertising
Considerations for Prescription Biological
Reference and Biosimilar Products Questions
and Answers Guidance for Industry |
2024-04-24 |
CDER; CBER |
|
Draft |
Data Integrity for In Vivo Bioavailability
and Bioequivalence Studies |
2024-04-03 |
CDER |
Generic Drugs |
Draft |
Draft Guidance for Industry: New Dietary
Ingredient Notification Master Files for
Dietary Supplements |
2024-04-03 |
Human Foods
Program |
|
Draft |
Draft Guidance for Industry: New Dietary
Ingredient Notifications and Related Issues |
2024-04-03 |
Human Foods
Program |
|
Draft |
Electronic Submission of Expedited Safety
Reports From IND-Exempt BA/BE Studies
Guidance for Industry |
2024-04-01 |
CDER |
Electronic
Submissions, Generic
Drugs |
Final |
Providing Regulatory Submissions in
Electronic Format: IND Safety Reports
Guidance for Industry |
2024-04-01 |
CDER; CBER; OCE |
Electronic
Submissions, |
Final |
Animal Studies for Dental Bone Grafting
Material Devices - Premarket Notification
(510(k)) Submissions: Draft Guidance for
Industry and Food and Drug Administration
Staff |
2024-03-29 |
CDRH |
Premarket, 510(k),
Dental |
Draft |
Handling and Retention of Bioavailability BA
and Bioequivalence BE Testing Samples: Draft
Guidance for Industry |
2024-03-27 |
CDER |
Generic Drugs, Good
Clinical Practice
(GCP) |
Draft |
Real-World Evidence: Considerations
Regarding Non-Interventional Studies for
Drug and Biological Products |
2024-03-21 |
OCE; CBER; CDER |
Real World Data / Real
World Evidence
(RWD/RWE), |
Draft |
Controlled Correspondence Related to Generic
Drug Development |
2024-03-18 |
CDER |
Drug Competition
Action Plan, Generic
Drugs |
Final |
CVM GFI #285 - Manufacture of Batches in
Support of Original NADAs, ANADAs, and
CNADAs |
2024-03-18 |
CVM |
Premarket, Current
Good Manufacturing
Practice (CGMP),
Chemistry,
Manufacturing, and
Controls (CMC),
Generic Animal Drugs,
New Animal Drug
Application (NADA),
Investigational New
Animal Drug (INAD) |
Draft |
Evaluation of Thermal Effects of Medical
Devices that Produce Tissue Heating and/or
Cooling: Draft Guidance for Industry and
Food and Drug Administration Staff |
2024-03-15 |
CDRH |
|
Draft |
Pharmacokinetics in Patients with Impaired
Renal Function — Study Design, Data
Analysis, and Impact on Dosing |
2024-03-15 |
CDER |
Clinical -
Pharmacology |
Final |
Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission
Program - Draft Guidance for Industry and
Food and Drug Administration Staff |
2024-03-15 |
CDRH; CBER |
Premarket,
Administrative /
Procedural |
Draft |
Annual Reportable Labeling Changes for New
Drug Applications and Abbreviated New Drug
Applications for Nonprescription Drug
Products |
2024-03-13 |
CDER |
Labeling |
Draft |
E2D(R1) Post-Approval Safety Data:
Definitions and Standards for Management and
Reporting of Individual Case Safety Reports |
2024-03-13 |
CDER; CBER |
ICH-Efficacy |
Draft |
Select Updates for the Premarket
Cybersecurity Guidance: Section 524B of the
FD&C Act: Draft Guidance for Industry and
Food and Drug Administration Staff |
2024-03-13 |
CDRH; CBER |
Premarket, |
Draft |
Early Alzheimer’s Disease: Developing
Drugs for Treatment |
2024-03-12 |
CBER; CDER |
Clinical - Medical |
Draft |
| Q14 Analytical Procedure Development |
2024-03-07 |
CDER\ORP; CBER |
ICH-Quality |
Final |
| Q2(R2) Validation of Analytical Procedures |
2024-03-06 |
CDER\ORP |
ICH-Quality |
Final |
Guidance for Industry: New Dietary
Ingredient Notification Procedures and
Timeframes - Dietary Supplements |
2024-03-05 |
Human Foods
Program |
Ingredients |
Final |
Clinical Pharmacology Considerations for
Antibody-Drug Conjugates Guidance for
Industry: Guidance for Industry |
2024-03-01 |
CDER; CBER |
Clinical -
Pharmacology |
Final |
Key Information and Facilitating
Understanding in Informed Consent Guidance
for Sponsors, Investigators, and
Institutional Review Boards |
2024-03-01 |
CDER; OC\OCPP |
Administrative /
Procedural |
Draft |
Reporting Amount of Listed Drugs and
Biological Products Technical Conformance
Guide: Guidance for Industry |
2024-02-26 |
CDER; CBER; CVM |
Administrative /
Procedural |
Final |
Assessing COVID-19-Related Symptoms in
Outpatient Adult and Adolescent Subjects in
Clinical Trials of Drugs and Biological
Products for COVID-19 Prevention or
Treatment : Guidance for Industry |
2024-02-22 |
CBER; CDER |
Infectious Disease,
Coronavirus, Clinical
- Medical |
Final |
Select Updates for the Medical Device User
Fee Small Business Qualification and
Certification Guidance: Draft Guidance for
Industry and Food and Drug Administration
Staff |
2024-02-22 |
CDRH |
User Fees, |
Draft |
Guidance for Industry: Foods Derived from
Plants Produced Using Genome Editing |
2024-02-21 |
Human Foods
Program |
Bioengineering / GMOs |
Final |
Charging for Investigational Drugs Under an
IND: Questions and Answers |
2024-02-14 |
CDER |
|
Final |
Use of Data Monitoring Committees in
Clinical Trials |
2024-02-13 |
CBER; CDRH; CDER |
Clinical - Medical |
Draft |
Notifying FDA of a Discontinuance or
Interruption in Manufacturing of Finished
Products or Active Pharmaceutical
Ingredients Under Section 506C of the FD&C
Act |
2024-02-06 |
CDER; CBER |
Administrative /
Procedural |
Draft |
Draft Guidance for Industry: Recommendations
for Collecting Representative Samples for
Food Testing Used as Evidence for Release of
Certain Fish and Fishery Products Subject to
Detention Without Physical Examination
(DWPE) and Removal of a Foreign
Manufacturer’s Goods from DWPE |
2024-02-05 |
Human Foods
Program |
Seafood/Seafood
Product |
Draft |
Reporting Amount of Listed Drugs and
Biological Products Under Section 510(j)(3)
of the FD&C Act |
2024-02-05 |
CDER |
Administrative /
Procedural |
Final |
Conducting Remote Regulatory Assessments
Questions and Answers: Draft Guidance for
Industry |
2024-02-02 |
Office of
Inspections and
Investigations |
Compliance,
Investigation &
Enforcement,
Inspection, Electronic
Submissions,
Regulation,
Administration,
Records, Import |
Draft |
Considerations for the Development of
Chimeric Antigen Receptor (CAR) T Cell
Products |
2024-01-31 |
CBER |
Chemistry,
Manufacturing, and
Controls (CMC),
Pharmacology/Toxicology,
Gene Therapy |
Final |
CVM GFI #188 Data Elements for Submission of
Veterinary Adverse Event Reports to the
Center for Veterinary Medicine |
2024-01-31 |
CVM |
Adverse Event
Reporting |
Final |
CVM GFI #214 (VICH GL35) Pharmacovigilance
of Veterinary Medicinal Products Electronic
Standards for Transfer of Data |
2024-01-31 |
CVM |
Adverse Event
Reporting, VICH |
Final |
Collection of Race and Ethnicity Data in
Clinical Trials and Clinical Studies for
FDA-Regulated Medical Products |
2024-01-30 |
OCE; CBER; CDRH;
CDER; OC\Office of
Minority Health
and Health Equity;
OC\Office of
Women's Health;
OC\OCPP;
OC\OCPP\OPT |
Clinical - Medical,
Pediatric Product
Development |
Draft |
Draft Guidance for Industry: Hazard Analysis
and Risk-Based Preventive Controls for Human
Food |
2024-01-30 |
Human Foods
Program |
|
Draft |
Human Gene Therapy Products Incorporating
Human Genome Editing: Guidance for Industry |
2024-01-29 |
CBER |
Gene Therapy |
Final |
CVM GFI #286 (VICH GL60) - Good
Manufacturing Practice for Active
Pharmaceutical Ingredients Used in
Veterinary Medicinal Products |
2024-01-25 |
CVM |
Postmarket, Premarket,
Compliance, Current
Good Manufacturing
Practice (CGMP),
Chemistry,
Manufacturing, and
Controls (CMC),
Generic Animal Drugs,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA),
VICH |
Draft |
ANDA Submissions – Amendments and Requests
for Final Approval to Tentatively Approved
ANDAs: Guidance for Industry |
2024-01-24 |
CDER |
Drug Competition
Action Plan, Generic
Drugs |
Final |
Revising ANDA Labeling Following Revision
of the RLD Labeling Guidance for Industry:
Guidance for Industry |
2024-01-24 |
CDER |
Generic Drugs |
Final |
Characterization of Metallic Coatings and/or
Calcium Phosphate Coatings on Orthopedic
Devices: Draft Guidance for Industry and
Food and Drug Administration Staff |
2024-01-23 |
CDRH |
Premarket, Orthopedic |
Draft |
