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Emergency: Draft Guidance for Industry and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Declaration under Section 564: Draft
Guidance for Laboratory Manufacturers and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 |
CVM GFI #187B Heritable Intentional Genomic
Alterations in Animals: The Approval Process |
2024-05-02 |
CVM |
Premarket,
Biotechnology,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Draft |
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 |
CFSAN |
|
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 Standards Catalog |
2024-04-16 |
CBER; CDRH; CDER;
CFSAN; CVM |
|
Final |
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 |
CFSAN |
|
Draft |
Draft Guidance for Industry: New Dietary
Ingredient Notifications and Related Issues |
2024-04-03 |
CFSAN |
|
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 |
FDA Regional Implementation Guide for
E2B(R3) Electronic Transmission of
Individual Case Safety Reports for Drug and
Biological Products |
2024-04-01 |
CDER |
ICH-Safety |
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 |
Study Data Technical Conformance Guide -
Technical Specifications Document |
2024-03-29 |
CDER |
|
Final |
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 |
CFSAN |
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 |
CFSAN |
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 |
Advanced Manufacturing Technologies
Designation Program |
2024-02-12 |
CBER; CDER |
Chemistry,
Manufacturing, and
Controls (CMC),
Pharmaceutical Quality |
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 |
CFSAN |
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 |
ORA |
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 |
CFSAN |
|
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 |
Q5A(R2) Viral Safety Evaluation of
Biotechnology Products Derived from Cell
Lines of Human or Animal Origin |
2024-01-10 |
CDER; CBER |
ICH-Quality |
Final |
Requests for Reconsideration at the Division
Level Under GDUFA |
2024-01-10 |
CDER |
User Fees, Generic
Drugs |
Draft |
Submission and Review of Sterility
Information in Premarket Notification
(510(k)) Submissions for Devices Labeled as
Sterile: Guidance for Industry and Food and
Drug Administration Staff |
2024-01-08 |
CBER; CDRH |
Premarket, 510(k) |
Final |
Reformulating Drug Products That Contain
Carbomers Manufactured With Benzene |
2023-12-28 |
CDER |
Chemistry,
Manufacturing, and
Controls (CMC),
Pharmaceutical Quality |
Final |
Potency Assurance for Cellular and Gene
Therapy Products |
2023-12-27 |
CBER |
Gene Therapy |
Draft |
Quality Considerations for Topical
Ophthalmic Drug Products |
2023-12-27 |
CDER |
Chemistry,
Manufacturing, and
Controls (CMC),
Pharmaceutical Quality |
Draft |
Direct-to-Consumer Prescription Drug
Advertisements: Presentation of the Major
Statement in a Clear, Conspicuous, and
Neutral Manner in Advertisements in
Television and Radio Format Final Rule
Questions and Answers |
2023-12-26 |
CBER; CDER |
Advertising |
Final |
Rare Diseases: Considerations for the
Development of Drugs and Biological Products |
2023-12-26 |
CDER; CBER |
Rare Diseases,
Pediatric Product
Development |
Final |
CVM GFI #61 Special Considerations,
Incentives, and Programs to Support the
Approval of New Animal Drugs for Minor Uses
and for Minor Species |
2023-12-22 |
CVM |
Premarket,
Aquaculture,
Investigational New
Animal Drug (INAD) |
Final |
Digital Health Technologies for Remote Data
Acquisition in Clinical Investigations |
2023-12-22 |
OCE; CBER; CDRH;
CDER |
Clinical - Medical |
Final |
Real-World Data: Assessing Registries To
Support Regulatory Decision-Making for Drug
and Biological Products |
2023-12-22 |
CDER; CBER; OCE |
Real World Data / Real
World Evidence
(RWD/RWE), Clinical -
Medical |
Final |
510(k) Third Party Review Program and Third
Party Emergency Use Authorization (EUA)
Review: Draft Guidance for Industry, Food
and Drug Administration Staff, and Third
Party Review Organizations |
2023-12-21 |
CDRH |
Premarket, 510(k),
Administrative /
Procedural |
Draft |
Data Standards for Drug and Biological
Product Submissions Containing Real-World
Data: Guidance for Industry |
2023-12-21 |
CDER; CBER |
Real World Data / Real
World Evidence
(RWD/RWE), |
Final |
Development of Monoclonal Antibody Products
Targeting SARS-CoV-2 for Emergency Use
Authorization |
2023-12-21 |
CDER |
Clinical - Medical |
Final |
Master Protocols for Drug and Biological
Product Development |
2023-12-21 |
CDER; CBER |
Clinical - Medical |
Draft |
CVM GFI #283 Priority Zoonotic Animal Drug
Designation and Review Process |
2023-12-18 |
CVM |
Premarket, Animal
Drugs, Investigational
New Animal Drug
(INAD), New Animal
Drug Application
(NADA) |
Draft |
Guidance for Industry: Registration and
Listing of Cosmetic Product Facilities and
Products |
2023-12-18 |
OC\Office of the
Chief Scientist |
|
Final |
Clinical Pharmacology Considerations for
Peptide Drug Products |
2023-12-14 |
CDER |
Clinical -
Pharmacology |
Draft |
Draft: Use of Real-World Evidence to Support
Regulatory Decision-Making for Medical
Devices: Draft Guidance for Industry and
Food and Drug Administration Staff |
2023-12-14 |
CDRH; CBER |
Postmarket, Real World
Data / Real World
Evidence (RWD/RWE),
Premarket, |
Draft |
Draft Guidance for Industry: Menu Labeling
Supplemental Guidance (Edition 2) |
2023-12-13 |
CFSAN |
Labeling, Nutrition |
Draft |
Presenting Quantitative Efficacy and Risk
Information in Direct-to-Consumer (DTC)
Promotional Labeling and Advertisements |
2023-12-12 |
CDER; CBER; CVM |
Advertising |
Final |
Interim Policy on Compounding Using Bulk
Drug Substances Under Section 503A of the
Federal Food, Drug, and Cosmetic Act |
2023-12-07 |
CDER |
Compounding |
Draft |
Interim Policy on Compounding Using Bulk
Drug Substances Under Section 503B of the
Federal Food, Drug, and Cosmetic Act -
Revision 2 |
2023-12-07 |
CDER |
Compounding |
Draft |
Verification Systems Under the Drug Supply
Chain Security Act for Certain Prescription
Drugs: Guidance for Industry |
2023-12-07 |
CDER\ORP |
Administrative /
Procedural |
Final |
CVM GFI #199 Animal Generic Drug User Fees
and Fee Waivers and Reductions |
2023-12-04 |
CVM |
User Fees, |
Final |
CVM GFI #284 Using Relative Supersaturation
to Support “Urinary Tract Health” Claims
for Adult Maintenance Cat Food |
2023-11-30 |
CVM |
Animal Feed, Labeling |
Draft |
Small Entity Compliance Guide: Milk and
Cream Products and Yogurt Products; Final
Rule to Revoke the Standards for Lowfat
Yogurt and Nonfat Yogurt and To Amend the
Standard for Yogurt |
2023-11-27 |
CFSAN |
Dairy |
Final |
COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention:
Guidance for Industry |
2023-11-24 |
CBER; CDER |
Infectious Disease,
Coronavirus, Clinical
- Medical |
Final |
Translation of Good Laboratory Practice
Study Reports: Questions and Answers |
2023-11-21 |
CDER |
|
Draft |
Assessing the Credibility of Computational
Modeling and Simulation in Medical Device
Submissions: Guidance for Industry and Food
and Drug Administration Staff |
2023-11-17 |
CDRH |
Premarket, Digital
Health |
Final |
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 |
2023-11-17 |
CDRH; CBER |
Postmarket, |
Final |
Select Updates for the 506J Guidance: 506J
Device List and Additional Notifications:
Draft Guidance for Industry and Food and
Drug Administration Staff |
2023-11-17 |
CDRH; CBER |
Postmarket, |
Draft |
Guidance for Industry: Compliance Policy for
Cosmetic Product Facility Registration and
Cosmetic Product Listing |
2023-11-08 |
OC\Office of the
Chief Scientist |
|
Final |
COVID-19 Container Closure System and
Component Changes: Glass Vials and Stoppers
Guidance for Industry: Guidance for
Industry |
2023-11-07 |
CBER |
|
Final |
Real-Time Oncology Review (RTOR) : Guidance
for Industry |
2023-11-07 |
OCE |
|
Final |
Submitting Clinical Trial Datasets and
Documentation for Clinical Outcome
Assessments Using Item Response Theory |
2023-11-06 |
CDER |
|
Final |
Submitting Patient-Reported Outcome Data in
Cancer Clinical Trials |
2023-11-06 |
CDER; OCE |
|
Final |
Enforcement Policy for Clinical Electronic
Thermometers: Guidance for Industry and
Food and Drug Administration Staff |
2023-11-03 |
CDRH |
Premarket, Postmarket,
Device & Drug Safety |
Final |
Process to Request a Review of FDA's
Decision Not to Issue Certain Export
Certificates for Devices: Guidance for
Industry and Food and Drug Administration
Staff |
2023-11-03 |
CDRH; CBER |
Postmarket, Export,
Import |
Final |
Enforcement Policy for Certain Supplements
for Approved Premarket Approval (PMA) or
Humanitarian Device Exemption (HDE)
Submissions: Guidance for Industry and Food
and Drug Administration Staff |
2023-11-02 |
CBER; CDRH |
HUD/HDE, Premarket
Approval (PMA) |
Final |
Remote Interactive Evaluations of Drug
Manufacturing and Bioresearch Monitoring
Facilities |
2023-10-26 |
CDER; CBER; CVM |
Current Good
Manufacturing Practice
(CGMP), Pharmaceutical
Quality |
Draft |
Communications From Firms to Health Care
Providers Regarding Scientific Information
on Unapproved Uses of Approved/Cleared
Medical Products Questions and Answers |
2023-10-24 |
CVM; CBER; CDRH;
CDER; OC |
Administrative /
Procedural |
Draft |
Topical Dermatologic Corticosteroids: In
Vivo Bioequivalence |
2023-10-24 |
CDER |
Drug Competition
Action Plan, Generic
Drugs |
Draft |
Development and Licensure of Vaccines to
Prevent COVID-19: Guidance for Industry |
2023-10-19 |
CBER |
Infectious Disease,
Coronavirus, Vaccines |
Final |
Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient
Monitoring: Guidance for Industry and Food
and Drug Administration Staff |
2023-10-19 |
CDRH |
Premarket, 510(k),
Labeling |
Final |
Voluntary Consensus Standards Recognition
Program for Regenerative Medicine Therapies:
Guidance for Industry |
2023-10-19 |
CBER |
Tissue |
Final |
Demonstrating the Substantial Equivalence of
a New Tobacco Product: Responses to
Frequently Asked Questions (Revised):
Guidance for Industry |
2023-10-18 |
CTP |
|
Final |
Establishing That a Tobacco Product Was
Commercially Marketed in the United States
as of February 15, 2007 (Revised): Guidance
for Industry |
2023-10-18 |
CTP |
|
Final |
Benefit-Risk Assessment for New Drug and
Biological Products |
2023-10-17 |
CBER; CDER |
Clinical - Medical |
Final |
Compliance Policy Regarding Blood and Blood
Component Donation Suitability, Donor
Eligibility and Source Plasma Quarantine
Hold Requirements: Guidance for Industry |
2023-10-17 |
CBER |
Blood, Coronavirus,
Blood Products |
Final |
Diabetic Foot Infections: Developing Drugs
for Treatment |
2023-10-17 |
CDER |
Clinical -
Antimicrobial |
Draft |
Policy for Testing of Alcohol (Ethanol) and
Isopropyl Alcohol for Methanol: Guidance
for Industry |
2023-10-17 |
CDER; CBER; CVM |
Current Good
Manufacturing Practice
(CGMP) |
Final |
Guidance for Industry: Prior Notice of
Imported Food Questions and Answers (Edition
4) |
2023-10-13 |
CFSAN; ORA; CVM |
Import |
Final |
Investigational COVID-19 Convalescent
Plasma: Guidance for Industry |
2023-10-13 |
CBER |
Blood, Infectious
Disease, Coronavirus,
Blood Products |
Final |
Submission of Premarket Notifications for
Magnetic Resonance Diagnostic Devices:
Guidance for Industry and Food and Drug
Administration Staff |
2023-10-10 |
CDRH |
Premarket, 510(k),
Radiological Health,
Radiology |
Final |
Testing and Labeling Medical Devices for
Safety in the Magnetic Resonance (MR)
Environment: Guidance for Industry and Food
and Drug Administration Staff |
2023-10-10 |
CDRH |
Premarket, Labeling,
Safety - Issues,
Errors, and Problems |
Final |
Stimulant Use Disorders: Developing Drugs
for Treatment |
2023-10-05 |
CDER |
Clinical - Medical |
Draft |
Electronic Submission Template for Medical
Device 510(k) Submissions: Guidance for
Industry and Food and Drug Administration
Staff |
2023-10-02 |
CDRH; CBER |
|
Final |
Human Prescription Drug and Biological
Products--Labeling for Dosing Based on
Weight or Body Surface Area for Ready-to-Use
Containers--“Dose Banding” |
2023-10-02 |
CBER; CDER |
Labeling |
Final |
Antimicrobial Susceptibility Test (AST)
System Devices – Updating Breakpoints in
Device Labeling: Guidance for Industry and
Food and Drug Administration Staff |
2023-09-29 |
CDRH |
Antimicrobial
Resistance |
Final |
Electronic Submission Template for Medical
Device De Novo Requests: Draft Guidance for
Industry and Food and Drug Administration
Staff |
2023-09-29 |
CBER; CDRH |
Premarket, Electronic
Submissions, |
Draft |
Technical Considerations for Medical Devices
with Physiologic Closed-Loop Control
Technology: Guidance for Industry and Food
and Drug Administration Staff |
2023-09-29 |
CDRH |
Premarket, Combination
Products, Clinical -
Medical, Digital
Health |
Final |
Draft Guidance for Industry: Standards for
the Growing, Harvesting, Packing, and
Holding of Sprouts for Human Consumption |
2023-09-28 |
CFSAN |
Vegetable Products |
Draft |
Graft-versus-Host Diseases: Developing
Drugs, Biological Products, and Certain
Devices for Prevention or Treatment |
2023-09-28 |
OCE |
|
Draft |
Guidance for Industry: Standards for the
Growing, Harvesting, Packing, and Holding of
Sprouts for Human Consumption |
2023-09-28 |
CFSAN |
Produce |
Final |
Cybersecurity in Medical Devices: Quality
System Considerations and Content of
Premarket Submissions: Guidance for
Industry and Food and Drug Administration
Staff |
2023-09-27 |
CDRH |
Premarket, Digital
Health |
Final |
CVM GFI #273 Defining Durations of Use for
Approved Medically Important Antimicrobial
Drugs Fed to Food-Producing Animals |
2023-09-26 |
CVM |
Premarket,
Antimicrobial
Resistance, Labeling,
New Animal Drug
Application (NADA) |
Draft |
Alternative Tools: Assessing Drug
Manufacturing Facilities Identified in
Pending Applications |
2023-09-22 |
CDER; CBER |
Current Good
Manufacturing Practice
(CGMP), Pharmaceutical
Quality |
Draft |
Formal Meetings Between the FDA and Sponsors
or Applicants of PDUFA Products |
2023-09-22 |
CDER; CBER |
Administrative /
Procedural |
Draft |
Considerations for the Conduct of Clinical
Trials of Medical Products During Major
Disruptions Due to Disasters and Public
Health Emergencies |
2023-09-21 |
CDER; CBER; CDRH;
OCE |
Emergencies, |
Final |
Guidance for Industry: Returning
Refrigerated Transport Vehicles and
Refrigerated Storage Units to Food Uses
After Using Them to Preserve Human Remains |
2023-09-20 |
CVM; CFSAN |
Transportation |
Final |
Demonstrating Substantial Evidence of
Effectiveness With One Adequate and
Well-Controlled Clinical Investigation and
Confirmatory Evidence |
2023-09-19 |
CDER; CBER; OCE;
OC |
Clinical - Medical |
Draft |
Regulatory Considerations for Prescription
Drug Use-Related Software |
2023-09-19 |
CDER; CBER; CDRH;
OCE |
Labeling |
Draft |
Biosimilarity and Interchangeability:
Additional Draft Q&As on Biosimilar
Development and the BPCI Act (Revision 1):
Draft Guidance for Industry |
2023-09-18 |
CDER; CBER |
Biosimilars,
Prescription Drugs |
Draft |
Labeling for Biosimilar and Interchangeable
Biosimilar Products |
2023-09-18 |
CDER; CBER |
Biosimilars |
Draft |
Annual Status Report Information and Other
Submissions for Postmarketing Requirements
and Commitments: Using Forms FDA 3988 and
FDA 3989 Guidance for Industry: Guidance
for Industry |
2023-09-15 |
CDER; CBER |
|
Final |
CVM GFI #282 Informed Consent Forms for
Studies that Enroll Client-Owned Companion
Animals |
2023-09-15 |
CVM |
Premarket,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA),
Target Animal –
Effectiveness |
Draft |
Fostering Medical Device Improvement: FDA
Activities and Engagement with the Voluntary
Improvement Program: Guidance for Industry
and Food and Drug Administration Staff |
2023-09-15 |
CDRH |
Postmarket, Current
Good Manufacturing
Practice (CGMP) |
Final |
Medical Devices with Indications Associated
with Weight Loss - Clinical Study and
Benefit-Risk Considerations: Draft Guidance
for Industry and Food and Drug
Administration Staff |
2023-09-15 |
CDRH |
Premarket,
Gastroenterology-Urology |
Draft |
Medical Devices with Indications Associated
with Weight Loss - Non-Clinical
Recommendations: Draft Guidance for Industry
and Food and Drug Administration Staff |
2023-09-15 |
CDRH |
Premarket,
Gastroenterology-Urology |
Draft |
Breakthrough Devices Program: Guidance for
Industry and Food and Drug Administration
Staff |
2023-09-14 |
CDRH; CBER |
|
Final |
Institutional Review Board (IRB) Review of
Individual Patient Expanded Access
Submissions for Investigational Drugs and
Biological Products: Guidance for IRBs and
Clinical Investigators |
2023-09-11 |
CDER; CBER; OCE |
Good Clinical Practice
(GCP) |
Final |
Endogenous Cushing’s Syndrome: Developing
Drugs for Treatment |
2023-09-08 |
CDER |
Clinical - Medical |
Draft |
Use of International Standard ISO 10993-1,
"Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk
management process" : Guidance for Industry
and Food and Drug Administration Staff |
2023-09-08 |
CDRH; CBER |
Premarket, 510(k),
Premarket Approval
(PMA), Investigational
Device Exemption
(IDE), HUD/HDE, Safety
- Issues, Errors, and
Problems |
Final |
Application of Human Factors Engineering
Principles for Combination Products:
Questions and Answers: Guidance for
Industry and FDA Staff |
2023-09-07 |
CBER; CDRH; CDER;
OC\OCPP\OCP |
Combination Products |
Final |
Best Practices for Selecting a Predicate
Device to Support a Premarket Notification
[510(k)] Submission: Draft Guidance for
Industry and Food and Drug Administration
Staff |
2023-09-07 |
CDRH; CBER |
Premarket, 510(k) |
Draft |
Evidentiary Expectations for 510(k) Implant
Devices: Draft Guidance for Industry and
Food and Drug Administration Staff |
2023-09-07 |
CDRH; CBER |
Premarket, 510(k) |
Draft |
Recommendations for the Use of Clinical Data
in Premarket Notification [510(k)]
Submissions: Draft Guidance for Industry and
Food and Drug Administration Staff |
2023-09-07 |
CDRH; CBER |
Premarket, 510(k) |
Draft |
DSCSA Standards for the Interoperable
Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs
Guidance for Industry |
2023-09-06 |
CDER; CBER; ORA |
Administrative /
Procedural |
Final |
Enforcement Policy for Face Masks and
Barrier Face Coverings During the
Coronavirus Disease (COVID-19) Public Health
Emergency : Guidance for Industry and Food
and Drug Administration Staff |
2023-09-05 |
CDRH |
Premarket,
Coronavirus, Labeling |
Final |
Nontuberculous Mycobacterial Pulmonary
Disease Caused by Mycobacterium avium
Complex: Developing Drugs for Treatment :
Guidance for Industry |
2023-09-05 |
CDER |
Clinical -
Antimicrobial |
Final |
| Post-Warning Letter Meetings Under GDUFA |
2023-09-05 |
CDER; ORA |
Generic Drugs |
Draft |
Wholesale Distributor Verification
Requirement for Saleable Returned Drug
Product and Dispenser Verification
Requirements When Investigating a Suspect or
Illegitimate Product—Compliance Policies |
2023-09-01 |
CDER; CBER; ORA |
Administrative /
Procedural |
Final |
Civil Money Penalties and No-Tobacco-Sale
Orders For Tobacco Retailers (*Revised):
Guidance for Industry |
2023-08-31 |
CTP |
No-tobacco-sale order
(NTSO) |
Final |
Considerations for the Use of Real-World
Data and Real-World Evidence To Support
Regulatory Decision-Making for Drug and
Biological Products: Guidance for Industry |
2023-08-30 |
CDER; CBER; OCE |
Real World Data / Real
World Evidence
(RWD/RWE), Clinical -
Medical |
Final |
Enhanced Drug Distribution Security at the
Package Level Under the Drug Supply Chain
Security Act: Guidance for Industry |
2023-08-30 |
ORA; CBER; CDER |
Administrative /
Procedural |
Final |
Enhanced Drug Distribution Security
Requirements Under Section 582(g)(1) of the
Federal Food, Drug, and Cosmetic
Act--Compliance Policies |
2023-08-28 |
CDER; CBER; ORA |
Administrative /
Procedural |
Final |
Guidance for Industry: The Seafood List
FDA’s Guide to Determine Acceptable
Seafood Names |
2023-08-22 |
CFSAN |
Seafood/Seafood
Product |
Final |
Informed Consent: Guidance for IRBs,
Clinical Investigators, and Sponsors |
2023-08-15 |
OC\OCPP\OCLiP\OGCP;
CDER; CDRH; CBER |
Good Clinical Practice
(GCP), Pediatric
Product Development |
Final |
Classification Categories for Certain
Supplements Under BsUFA III |
2023-08-11 |
CDER; CBER |
Biosimilars |
Draft |
Formal Meetings Between the FDA and Sponsors
or Applicants of BsUFA Products Guidance for
Industry |
2023-08-11 |
CDER |
Administrative /
Procedural,
Biosimilars |
Draft |
Off-The-Shelf Software Use in Medical
Devices: Guidance for Industry and Food and
Drug Administration Staff |
2023-08-11 |
CDRH |
Premarket, Digital
Health |
Final |
Postmarketing Approaches to Obtain Data on
Populations Underrepresented in Clinical
Trials for Drugs and Biological Products |
2023-08-10 |
OCE |
Clinical - Medical |
Draft |
QTc Information in Human Prescription Drug
and Biological Product Labeling: Draft
Guidance for Industry |
2023-08-08 |
OCE; CDER; CBER |
Labeling |
Draft |
Recommended Acceptable Intake Limits for
Nitrosamine Drug Substance-Related
Impurities |
2023-08-07 |
CDER |
Pharmacology/Toxicology |
Final |
Waivers, Exceptions, and Exemptions from the
Requirements of Section 582 of the Federal
Food, Drug, and Cosmetic Act |
2023-08-04 |
CBER; CDER |
Administrative /
Procedural |
Final |
PDUFA Waivers, Reductions, and Refunds for
Fixed- Combinations and Single-Entity
Versions of Previously Approved
Antiretrovirals under PEPFAR |
2023-08-03 |
CDER |
User Fees, |
Draft |
Fixed-Combinations and Single-Entity
Versions of Previously Approved
Antiretrovirals for the Treatment or
Prevention of Human Immunodeficiency
Virus-One Under the President’s Emergency
Plan for Acquired Immunodeficiency Syndrome
Relief |
2023-08-01 |
CDER |
Administrative /
Procedural |
Draft |
Assessing User Fees Under the Biosimilar
User Fee Amendments of 2022: Guidance for
Industry |
2023-07-31 |
CBER; CDER |
User Fees, |
Final |
Clinical Considerations for Studies of
Devices Intended to Treat Opioid Use
Disorder: Draft Guidance for Industry and
Food and Drug Administration Staff |
2023-07-28 |
CDRH |
|
Draft |
Hydrogen Peroxide-Based Contact Lens Care
Products: Consumer Labeling Recommendations
- Premarket Notification (510(k))
Submissions: Guidance for Industry and Food
and Drug Administration Staff |
2023-07-27 |
CDRH |
Premarket, 510(k),
Labeling, Ophthalmic |
Final |
CDER’s Program for the Recognition of
Voluntary Consensus Standards Related to
Pharmaceutical Quality |
2023-07-26 |
CDER |
Administrative /
Procedural, Drug
Competition Action
Plan |
Final |
Guidance for Industry | M7(R2) Assessment
and Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals To Limit
Potential Carcinogenic Risk |
2023-07-25 |
CDER; CBER |
ICH-Multidisciplinary |
Final |
M7(R2) ADDENDUM: APPLICATION OF THE
PRINCIPLES OF THE ICH M7 GUIDELINE TO
CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE
INTAKES: Guidance for Industry |
2023-07-25 |
CDER; CBER |
ICH-Multidisciplinary |
Final |
Questions and Answers | M7(R2) Assessment
and Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals To Limit
Potential Carcinogenic Risk: Guidance for
Industry |
2023-07-25 |
CDER; CBER |
ICH-Multidisciplinary |
Final |
Guidance for Industry: FDA's Voluntary
Qualified Importer Program |
2023-07-21 |
CVM; ORA; CFSAN |
Import |
Final |
Qualification of Medical Device Development
Tools: Guidance for Industry, Tool
Developers, and Food and Drug Administration
Staff |
2023-07-17 |
CDRH |
Premarket,
Administrative /
Procedural, Digital
Health |
Final |
Postmarketing Studies and Clinical Trials:
Determining Good Cause for Noncompliance
with Section 505(o)(3)(E)(ii) of the Federal
Food, Drug, and Cosmetic Act: Draft Guidance
for Industry |
2023-07-14 |
CDER; CBER |
|
Draft |
Manufacturing Changes and Comparability for
Human Cellular and Gene Therapy Products |
2023-07-13 |
CBER |
Gene Therapy |
Draft |
Temporary Policy Regarding Accredited
Third-Party Certification Program Onsite
Observation and Certificate Duration
Requirements Due to COVID-19 : Guidance for
Industry |
2023-07-13 |
CFSAN; CVM; ORA |
Infectious Disease,
Coronavirus, |
Final |
Temporary Policy Regarding Preventive
Controls and FSVP Food Supplier Verification
Onsite Audit Requirements Due to COVID-19:
Guidance for Industry |
2023-07-13 |
CFSAN |
Infectious Disease,
Coronavirus, |
Final |
Inborn Errors of Metabolism That Use Dietary
Management: Considerations for Optimizing
and Standardizing Diet in Clinical Trials
for Drug Product Development: Draft Guidance
for Industry |
2023-07-12 |
CDER; CBER |
Clinical - Medical,
Pediatric Product
Development |
Draft |
Chronic Rhinosinusitis with Nasal Polyps:
Developing Drugs for Treatment : Guidance
for Industry |
2023-06-28 |
CDER; CBER |
Clinical - Medical,
Pediatric Product
Development |
Final |
Patient-Matched Guides to Orthopedic
Implants: Draft Guidance for Industry and
Food and Drug Administration Staff |
2023-06-28 |
CDRH |
Premarket, Orthopedic |
Draft |
Prohibition on Wholesaling Under Section
503B of the Federal Food, Drug, and Cosmetic
Act |
2023-06-27 |
CDER |
Compounding |
Draft |
Alternative Procedures for the Manufacture
of Cold-Stored Platelets Intended for the
Treatment of Active Bleeding when
Conventional Platelets Are Not Available or
Their Use Is Not Practical: Guidance for
Industry |
2023-06-23 |
CBER |
Blood, Blood Products |
Final |
Formal Dispute Resolution and Administrative
Hearings of Final Administrative Orders
Under Section 505G of the Federal Food,
Drug, and Cosmetic Act |
2023-06-23 |
CDER |
Administrative /
Procedural |
Draft |
Psychedelic Drugs: Considerations for
Clinical Investigations |
2023-06-23 |
CDER |
Clinical - Medical |
Draft |
Drug-Drug Interaction Assessment for
Therapeutic Proteins Guidance for Industry:
Guidance for Industry |
2023-06-22 |
CBER; CDER |
Clinical -
Pharmacology |
Final |
Oncology Drug Products Used with Certain In
Vitro Diagnostic Tests: Pilot Program:
Guidance for Industry, Clinical
Laboratories, and Food and Drug
Administration Staff |
2023-06-20 |
OCE; CDER; CDRH |
|
Final |
CVM GFI #171 - Demonstrating Bioequivalence
for Soluble Powder Oral Dosage Form Products
and Type A Medicated Articles Containing
Active Pharmaceutical Ingredients Considered
to Be Soluble in Aqueous Media |
2023-06-16 |
CVM |
Premarket,
Aquaculture, Generic
Animal Drugs,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Final |
Content of Premarket Submissions for Device
Software Functions: Guidance for Industry
and Food and Drug Administration Staff |
2023-06-14 |
CDRH; CBER;
OC\OCPP\OCP; CDER |
Premarket, Digital
Health |
Final |
Implementation of Acceptable Full-Length and
Abbreviated Donor History Questionnaires and
Accompanying Materials for Use in Screening
Donors of Source Plasma: Guidance for
Industry |
2023-06-14 |
CBER |
Blood, Blood Products |
Final |
Draft Guidance for Industry: Insanitary
Conditions in the Preparation, Packing, and
Holding of Tattoo Inks and the Risk of
Microbial Contamination |
2023-06-12 |
CFSAN |
Tattoos |
Draft |
Assessing User Fees Under the Generic Drug
User Fee Amendments of 2022 |
2023-06-09 |
CDER |
User Fees, Generic
Drugs |
Final |
Clinical Drug Interaction Studies With
Combined Oral Contraceptives Guidance for
Industry: Guidance for Industry |
2023-06-08 |
CDER |
Clinical -
Pharmacology |
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 |
2023-06-08 |
CVM |
Premarket, Generic
Animal Drugs,
Investigational New
Animal Drug (INAD),
New Animal Drug
Application (NADA) |
Draft |
| E6(R3) GOOD CLINICAL PRACTICE (GCP) |
2023-06-06 |
CDER; CBER |
ICH-Efficacy |
Draft |
Cover Letter Attachments for Controlled
Correspondences and ANDA Submissions:
Guidance for Industry |
2023-06-05 |
CDER |
Generic Drugs |
Final |
Nonclinical Evaluation of the Immunotoxic
Potential of Pharmaceuticals |
2023-06-05 |
CDER |
Pharmacology/Toxicology |
Final |
Interstitial Cystitis/Bladder Pain Syndrome:
Establishing Drug Development Programs for
Treatment: Draft Guidance for Industry |
2023-06-02 |
CDER |
Clinical - Medical |
Draft |
Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission
Program: Guidance for Industry and Food and
Drug Administration Staff |
2023-06-02 |
CDRH; CBER |
Administrative /
Procedural,
Investigational Device
Exemption (IDE) |
Final |
Guidance for Industry: Action Level for
Inorganic Arsenic in Apple Juice |
2023-06-01 |
CFSAN |
Arsenic, Juice |
Final |
Migraine: Developing Drugs for Preventive
Treatment |
2023-06-01 |
CDER |
Clinical - Medical |
Draft |
Adjusting for Covariates in Randomized
Clinical Trials for Drugs and Biological
Products |
2023-05-26 |
CDER; CBER |
|
Final |
Non-Clinical Performance Assessment of
Tissue Containment Systems Used During Power
Morcellation Procedures: Guidance for
Industry and Food and Drug Administration
Staff |
2023-05-26 |
CDRH |
Premarket, Clinical -
Medical, General &
Plastic Surgery ,
Obstetrical &
Gynecological |
Final |
Diabetes Mellitus: Efficacy Endpoints for
Clinical Trials Investigating Antidiabetic
Drugs and Biological Products |
2023-05-25 |
CDER |
Clinical - Medical,
Pediatric Product
Development |
Draft |
Generally Accepted Scientific Knowledge in
Applications for Drug and Biological
Products: Nonclinical Information |
2023-05-24 |
CDER; CBER |
Pharmacology/Toxicology |
Draft |
Use of Whole Slide Imaging in Nonclinical
Toxicology Studies: Questions and Answers:
Guidance for Industry |
2023-05-24 |
CVM; ORA; CFSAN |
Pharmacology/Toxicology |
Final |
