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Application Submissions Guidances

by | Sep 12, 2024 | News | 0 comments

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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

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  • Providing Regulatory Submissions in Electronic Format: IND Safety Reports; Draft Guidance for Industry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and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff
    CBER, March 2019 (This guidance finalizes the draft guidance of the same title dated December 2017.)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

  • Charging for Investigational Drugs Under an IND — Qs & As; Guidance for Industry
    CDER/CBER. June 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

  • Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria; Guidance for Industry, FDA Staff, and Third Parties
    CDRH/CBER, August 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

  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff
    CDRH/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

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