Application Submissions Guidances

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• Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications; Guidance for Industry
  CDER/CBER, September 2024

• Providing Regulatory Submissions in Electronic Format: IND Safety Reports; Guidance for Industry
  CDER/CBER/OCE, April 2024

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

• Study Data Technical Conformance Guide - Technical Specifications Document; Guidance for Industry
  CDER/CBER, May 2023

• Identification of Medicinal Products — Implementation and Use; Guidance for Industry
  CDER/CBER, March 2023

• Electronic Submission of IND Safety Reports Technical Conformance Guide; Guidance for Industry
  CDER/CBER/OCE, April 2022

• Providing Submissions in Electronic Format—Postmarketing Safety Reports; Guidance for Industry
  CDER/CBER, April 2022

• Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs; Guidance for Industry
  CDER/CBER, April 2022

• Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry
  CDER/CBER, July 2021

• Providing Regulatory Submissions in Electronic Format - Standardized Study Data; Guidance for Industry
  CDER/CBER, June 2021

• Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Guidance for Industry
  CDER/CBER, December 2020

• Qualification Process for Drug Development Tools; Guidance for Industry and FDA Staff
  CDER/CBER, November 2020

• Electronic Submission of IND Safety Reports Technical Conformance Guide; Guidance for Industry
  CDER/CBER/OCE, October 2019

• Providing Regulatory Submissions in Electronic Format: IND Safety Reports; Draft Guidance for Industry
  CDER/CBER/OCE, October 2019

• Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff
  CBER, March 2019 (This guidance finalizes the draft guidance of the same title dated December 2017.)

• Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, February 2019

• Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format; Guidance for Industry
  CBER, February 2019

• Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings; Draft Guidance for Industry
  CDER/CBER, October 2018

• Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document
  CBER, April 2018

• Formal Meetings With Sponsors and Applicants for PDUFA Products; Draft Guidance for Industry
  CDER/CBER, December 2017

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

• Expanded Access to Investigational Drugs for Treatment Use - Qs & As
  CDER/CBER, October 2017

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

• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2017

• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2017

• Tropical Disease Priority Review Vouchers; Guidance for Industry
  CDER/CBER, October 2016

• Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information; Guidance for Industry
  CDER/CBER, April 2016

• Contents of a Complete Submission for the Evaluation of Proprietary Names; Guidance for Industry
  CDER/CBER, April 2016

• Product Development Under the Animal Rule; Guidance for Industry
  CDER/CBER, October 2015

• Integrated Summary of Effectiveness; Guidance for Industry
  CDER/CBER, October 2015

• Providing Submissions in Electronic Format -€” Postmarketing Safety Reports for Vaccines; Guidance for Industry
  CBER, August 2015

• Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry
  CBER, July 2015

• Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators; Draft Guidance for Industry
  CDER/CBER, May 2015

• Electronic Submission of Lot Distribution Reports; Guidance for Industry
  CBER/CDER, March 2015

• Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
  CDER/CBER, December 2014

• Providing Submissions in Electronic Format -- Standardized Study Data
  CDER/CBER, December 2014

• Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
  CBER/CDER/OOPD, November 2014

• Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, July 2014

• Providing Submissions in Electronic Format - Postmarketing Safety Reports; Draft Guidance for Industry
  CDER/CBER, June 2014

• Annual Reports for Approved Premarket Approval Applications (PMA); Draft Guidance for Industry and FDA Staff
  CDRH/CBER, February 2014

• Providing Regulatory Submissions in Electronic Format--Receipt Date; Draft Guidance for Industry
  CDER/CBER, February 2014

• eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff
  CDER/CBER, October 2013

• Electronic Source Data in Clinical Investigations; Guidance for Industry
  CDER/CBER/CDRH, September 2013

• Providing Submissions in Electronic Format - Postmarket Non-Expedited ICSRs Technical Questions and Answers; Guidance for Industry
  CDER/CBER, July 2013

• Humanitarian Device Exemption (HDE) Regulation: Questions and Answers; Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff
  CDRH/CBER, July 2010

• In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions; Guidance for Industry and FDA Staff
  CDRH/CBER, June 2010 (This document supersedes "Guidance for FDA Staff: Regulating In Vitro Diagnostic Device (IVD)Studies," issued December 17, 1999

• Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); Guidance for Industry
  CBER, May 2010

• Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages; Guidance for Industry
  OC/CDER/CBER/ORA, March 2010

• Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes; Guidance for Industry
  CDER/CVM/CBER, February 2010

• Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects; Guidance for Industry
  CDER/CBER/CDRH, October 2009

• Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing; Guidance for Industry
  CDER/CBER/CVM, May 2009

• Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process; Guidance for Industry and FDA Staff
  CDRH/CBER, December 2008

• Cooperative Manufacturing Arrangements for Licensed Biologics; Guidance for Industry
  CBER/CDER, November 2008

• Pharmacogenomic Data Submissions - Companion Guidance; Draft Guidance for Industry
  CDER/NCTR/CBER/CDRH, August 2007

• Bundling Multiple Devices or Multiple Indications in a Single Submission; Guidance for Industry and FDA Staff
  CDRH/CBER, June 2007

• Real-Time Premarket Approval Application (PMA) Supplements; Guidance for Industry and FDA Staff
  CBER/CDRH, April 2006

• Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997; Guidance for Industry
  CDER/CBER, February 2006

• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA; Guidance for Industry
  CDER/CBER/CVM/ORA, January 2006

• How to Comply with the Pediatric Research Equity Act; Draft Guidance for Industry
  CDER/CBER, September 2005

• Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients; Guidance for Industry
  CDER/CBER, May 2005

• Providing Regulatory Submissions in Electronic Format - Content of Labeling; Guidance for Industry
  CDER/CBER, April 2005

• Pharmacogenomic Data Submissions; Guidance for Industry
  CDER/CBER/CDRH, March 2005

• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees; Guidance for Industry
  CDER/CBER, December 2004

• Premarket Approval Application Modular Review; Guidance for Industry and FDA Staff
  CDRH/CBER, November 2003

• Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
  CDRH, February 2003

• Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs)
  CBER, March 2002

• Cancer Drug and Biological Products - Clinical Data in Marketing Applications; Guidance for Industry
  CDER/CBER, October 2001

• Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001; Draft Guidance for Industry
  CDER/CBER, August 2001

• Submitting and Reviewing Complete Responses to Clinical Holds; Guidance for Industry
  CDER/CBER, October 2000

• Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers; Guidance for Industry
  CDER/CBER, October 2000

• Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications; Guidance for Industry
  CBER, November 1999

• Submission of Abbreviated Reports and Synopses in Support of Marketing Applications; Guidance for Industry
  CDER/CBER, August 1999

• Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees; Guidance for Industry
  CDER/CBER, October 1998

• Submitting Debarment Certification Statements; Draft Guidance for Industry
  CDER/CBER/CVM, September 1998

• Guidance for Industry: Standards for Prompt Review of Efficacy Supplements
  CDER/CBER, May 1998

• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products; Guidance for Industry
  CDER/CBER, November 1995

• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products; Guidance for Industry
  CDER/CVM, November 1994

• Preparation of Investigational New Drug Products (Human and Animal); Guidance for Industry
  CDER, November 1992