Administrative Guidances

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• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry
  CDER/CBER/CORH/CSFAN/CDT/CVM/ORA/OCLiP/OCE, October 2024

• Container Closure System and Component Changes: Glass Vials and Stoppers; Guidance for Industry
  CDER/CBER, July 2024

• Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
  CDER/CBER/OCE, July 2024

• Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products; Draft Guidance for Industry and FDA Staff
  CDER/CBER/CDRH/OCP, July 2024

• Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry
  OCP/CBER/CDER/CDRH, June 2024

• Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry
  ORA/OCP/CBER/CDER/CDRH/CFSAN/CTP/CVM, June 2024

• Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry
  CBER, June 2024

• Platform Technology Designation Program for Drug Development; Draft Guidance for Industry
  CDER/CBER, May 2024

• REMS Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry

• CDER/CBER, May 2024

• Data Standards Catalog; Guidance for Industry
  CDER/CBER//CDRH/CFSAN/CVM, April 2024

• Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry
  CDER/CBER/OCE, March 2024

• Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards
  CDER/CBER/CDRH/OCLiP/OHRP, March 2024

• Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry
  CDER/CBER/CVM, February 2024

• Charging for Investigational Drugs Under an IND: Questions and Answers; Guidance for Industry
  CDER/CBER/OCE, February 2024

• Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Guidance for Industry
  CDER/CBER/CVM, February 2024

• Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry
  CDER/CBER, February 2024

• Conducting Remote Regulatory Assessments Questions and Answers; Draft Guidance for Industry
  ORA/OFPR/OCP/CBER/CDER/CDRH/OC/OCE/CFSAN/CTP/CVM, February 2024

• Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry
  CDER/CBER, December 2023

• Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry
  CDER/CBER/ORA, December 2023

• Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry
  CDER/CBER/CDRH/CVM/OC, October 2023

• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry
  CDER/CBER, September 2023

• Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry
  CDER/CBER, September 2023

• Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff
  OCP/CDRH/CDER/CBER, September 2023

• DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry
  CDER/CBER/ORA, September 2023

• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies; Guidance for Industry
  CDER/CBER/ORA, September 2023

• Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry
  CDER/CBER/ORA, August 2023

• Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies; Guidance for Industry
  CDER/CBER/ORA, August 2023

• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products; Draft Guidance for Industry
  CDER/CBER, August 2023

• Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry
  CDER/CBER, August 2023

• Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes; Guidance for Industry
  CDER/CBER/OCE, May 2023

• Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry
  CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, May 2023

• Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry
  CDER/CBER, May 2023

• Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry
  CDER/CBER, May 2023

• Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act; Draft Guidance for Industry
  CDER/CBER, May 2023

• A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers; Guidance for Industry
  CDER/CBER/CDRH/OCLiP/ORA, April 2023

• Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
  CDER/CBER/CDRH, April 2023

• Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry
  CDER/CBER, April 2023

• Pharmacogenomic Data Submissions; Draft Guidance for Industry
  CDER/CBER/NCTR, March 2023

• Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Guidance for Industry
  CDER/CBER, March 2023

• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/CDRH/CFSAN/CTP/CVM/ORA/OCLiP, March 2023

• Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry
  CDER/CBER, February 2023

• Format and Content of a REMS Document; Guidance for Industry
  CDER/CBER, January 2023

• Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe; Guidance for Industry
  CDER/CBER, December 2022

• Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/OCLiP/OCE, November 2022

• Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry
  CDER/CBER/OCE, September 2022

• Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry
  CDER/CBER, July 2022

• Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
  CDER/CBER/CDRH, June 2022

• Considerations for Rescinding Breakthrough Therapy Designation; Draft Guidance for Industry
  CDER/CBER/OCE, June 2022

• Risk Management Plans to Mitigate the Potential for Drug Shortages; Draft Guidance for Industry
  CDER/CBER/CGMP, May 2022

• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors; Guidance for Industry
  CDER/CBER, May 2022

• Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, April 2022

• Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4; Guidance for Industry
  CDER/CBER/CDRH/OCP, March 2022

• Expansion Cohorts: Use in First-in-Human Clinical Trials; Guidance for Industry
  CDER/CBER, March 2022

• Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry
  CDER/CBER/OCE, March 2022

• Drug Product Tracing: The Effect of Section 585 of the FD&C Act - Questions and Answers; Guidance for Industry
  CDER/CBER/ORA, February 2022

• Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
  CDER/CBER, February 2022

• Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry
  CDER/CBER/CDRH, September 2021

• FDA Export Certification; Guidance for Industry
  CDER/CBER/CDRH/CFSAN/CVM, August 2021

• Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry
  CDER/CBER, June 2021

• Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act; Draft Guidance for Industry
  CDER/CBER, June 2021

• Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry
  CDER/CBER/ORA, June 2021

• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1); Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)
  CDER/CBER/OGCP, May 2021

• Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
  CDER/CBER, December 2020

• Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry
  CDER/CBER, December 2020

• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Guidance for Industry
  CDER/CBER, November 2020

• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies; Guidance for Industry
  CDER/CBER/ORA, October 2020

• Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry
  CDER/CBER, August 2020

• Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans; Guidance for Industry
  CDER/CBER, July 2020

• Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic; Guidance for Industry
  OCET/CDER/CBER/CDRH/CFSAN, March 2020

• Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products; Draft Guidance for Industry
  CDER/CBER/CDRH/OCP, March 2020

• The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Guidance for Industry
  CDER/CBER, March 2020

• Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry
  CDER/CBER/CDRH, December 2019

• Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
  CBER/CDER/ORA, December 2019

• FDA Safe Importation Action Plan
  OPPLA/CBER,  December 2019

• FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act; Draft Guidance for Industry
  OCE/CDER/CBER, December 2019

• Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Guidance for Industry
  CDER/CBER/CDRH, October 2019

• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy; Guidance for Industry
  CDER/CBER/ORA,  September 2019

• Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry
  CDER/CBER, July 2019

• Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/CDRH/CVM/CFSAN/CTP, July 2019

• FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary; Guidance for Industry
  CDER/CBER,  April 2019

• Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
  OCP/CBER/CDER/CDRH, April 2019

• REMS Assessment: Planning and Reporting; Draft Guidance for Industry
  CDER/CBER, January 2019

• Survey Methodologies to Assess REMS Goals That Relate to Knowledge; Draft Guidance for Industry
  CDER/CBER, January 2019

• Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders
  CDER/CBER, December 2018

• Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry
  CDER/CBER, December 2018

• Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry
  CDER/CBER/OCE, September 2018

• Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff
  CDER/CBER, September 2018

• Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry
  CDER/CBER/ORA, September 2018

• Product Identifier Requirements Under the Drug Supply Chain Security Act Compliance Policy; Guidance for Industry
  CDER/CBER/ORA, September 2018

• Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry
  CDER/CBER/OCE, August 2018

• Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry
  CDER/CBER/CDRH, July 2018

• Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry
  CDER/CBER, June 2018

• Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers; Guidance for Industry
  CDER/CBER/CDRH/CVM/OC, June 2018

• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers; Guidance for Industry and Review Staff
  CDER/CBER/CDRH/OC, June 2018

• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products; Draft Guidance for Industry
  CDER/CBER, June 2018

• Patient-Focused Drug Development: Collecting Comprehensive and Representative Input; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
  CDER/CBER, June 2018

• Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry
  CDER/CBER, June 2018

• Development of a Shared System REMS; Draft Guidance for Industry
  CDER/CBER, June 2018

• Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry
  CDER/CBER/CDRH, April 2018

• Special Protocol Assessment; Guidance for Industry
  CDER/CBER, April 2018

• Standardization of Data and Documentation Practices for Product Tracing; Draft Guidance for Industry
  CDER/CBER/ORA, March 2018

• Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry
  CDER/CBER, January 2018

• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry
  CDER/CBER, December 2017

• Best Practices for Communication Between IND Sponsors and FDA During Drug Development; Guidance for Industry and Review Staff
  CDER/CBER, December 2017

• Use of a Drug Master File for Shared System REMS Submissions; Draft Guidance for Industry
  CDER/CBER, November 2017

• Formal Dispute Resolution: Appeals Above the Division Level; Guidance for Industry
  CDER/CBER, November 2017

• Individual Patient Expanded Access Applications: Form FDA 3926; Guidance for Industry
  CDER/CBER, October 2017

• Expedited Programs for Serious Conditions - €“Drugs and Biologics; Guidance for Industry
  CDER/CBER, September 2017

• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2017 (This document was originally issued on November 2, 2000.)

• Dear Health Care Provider Letters: Improving Communication of Important Safety Information
  CDER/CBER, February 2017

• Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act - €” Compliance Policy; Guidance for Industry
  CDER/CBER/ORA, February 2017

• Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft Guidance for Industry
  CDER/CBER, January 2017

• Use of Electronic Informed Consent in Clinical Investigations - Questions and Answers
  OHRP/CDER/OGCP/CBER/CDRH, December 2016

• Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry
  CDER/CBER/ORA, December 2016

• Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff
  CDER/CBER/CDRH/CFSAN/CTP/NCTR, June 2016

• Integrated Summary of Effectiveness
  CDER/CBER, October 2015

• DSCSA Implementation: Product Tracing Requirements for Dispensers - Compliance Policy Guidance for Industry
  CDER/CBER/ORA, October  2015

• User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Guidance for Industry
  CDER/CBER, January 2015

• DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
  CDER/CBER, December 2014

• Specification of the Unique Facility Identifier (UFI) System for Drug Establishment
  CDER/CBER/CVM/ORA, November 2014

• Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products - €”Recommended Practices; Draft Guidance for Industry
  CDER/CBER/CVM, June 2014

• Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide; Guidance for Industry
  CDER/CBER, December 2012

• Safety Reporting Requirements for INDs and BA/BE Studies ; Guidance for Industry and Investigators
  CDER/CBER, December 2012