Title | Organization(s) | Date |
|---|
| 2013 | | |
| Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)(This document supersedes “User Fees and Refunds for Premarket Notification Submissions (510(k)s)” issued August 27, 2009) | CDRH/CBER | April
2013 |
| Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications (This document supersedes “User Fees and Refunds for Premarket Approval Applications” dated November 24, 2003.) | CDER/CBER | April
2013 |
| | | |
| 2012 | | |
Draft Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s (PDF - 144MB) (This guidance document provides updated information to two existing guidance documents entitled "Center for Devices and Radiological Health's Premarket Notification (510(k)) Refuse to Accept Policy" issued on June 30, 1993, and "510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1" issued on May 20, 1994. | CDER/CBER | August
2012 |
Draft Guidance for Industry: Compliance Policy on Reporting Drug Sample Distribution Information (PDF - 92KB) | CDER/CBER | April
2012 |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Standardized Study Data (PDF - 453KB) | CDER/CBER/CDRH | February 2012 |
| | | |
| 2010 | | |
Draft Guidance for Industry: Electronic Source Documentation in Clinical Investigations (PDF - 166KB)
| CDER/CBER | December 2010 |
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF - 138KB) (This document supersedes: Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers, issued July 18, 2006. The draft of this document was issued on August 5, 2008)
| CDRH/CBER | July 2010 |
Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB) (The draft of this document was issued on October 25, 2007. This document supersedes "Guidance for FDA Staff: Regulating In Vitro Diagnostic Device (IVD) Studies," issued December 17, 1999)
| CDRH/CBER | June 2010 |
Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) (PDF - 56KB)
| CBER | April 2010 |
Final Guidance for Industry -Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
| OC/CDER/CBER/ORA
| March 2010 |
Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
| CDER/CBER | February 2010 |
| Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB) | CDER/CVM/CBER | February 2010 |
| | | |
| 2009 | | |
Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF - 295KB)
| CDER/CBER/CDRH | December 2009 |
Draft Guidance for Industry: SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
| CDER/CBER
| October 2009 |
Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB)
| CDER/CBER/CDRH | October 2009 |
Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 123KB)
| CDER/CBER/CVM | May 2009 |
| | | |
| 2008 | | |
Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF - 180KB) (This document supersedes “Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process” dated March 9, 2007.)
| CDRH/CBER | December 2008 |
Draft Guidance for Industry: Tropical Disease Priority Review Vouchers (PDF - 112KB)
| CDER/CBER | October 2008 |
Draft Guidance for Industry: Integrated Summary of Effectiveness (PDF - 95KB)
| CDER/CBER | August 2008 |
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports (PDF - 107KB)
| CDER/CBER | June 2008 |
Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 133KB)
| CDER/CBER | June 2008 |
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals (PDF - 155KB) (This document supersedes “FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment” dated October 8, 2003.)
| CDRH/CBER | June 2008 |
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF - 103KB)
| CDRH/CBER | February 2008 |
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF - 127KB)
| CDRH/CBER | February 2008 |
| | | |
| 2007 | | |
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols (PDF - 76KB)
| CBER | November 2007 |
Draft Guidance for Industry: Pharmacogenomic Data Submissions — Companion Guidance (PDF - 211KB)
| CDER/NCTR/CBER/CDRH | August 2007 |
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission (PDF - 145KB) (This guidance supersedes the document issued under this title on November 26, 2003)
| CDRH/CBER | June 2007 |
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 59KB)
| CDER/CBER | June 2007 |
| | | |
| 2006 | | |
Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) (PDF - 127KB)
| CDRH/CBER | October 2006 |
Guidance for Industry and FDA Staff: Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF - 82KB) (This document supersedes and replaces, the “Real-Time” Review Program for Premarket Approval Application (PMA) Supplements document last updated April 22, 1997 and Section II C, “PMA Supplements Definitions – Real Time Supplements” of the February 2003 guidance entitled, “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA”)
| CBER/CDRH | April 2006 |
Guidance for Industry: Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB)
| CDER/CBER | February 2006 |
Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110KB)
| CDER/CBER/CVM/ORA | January 2006 |
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB)
| CDER/CBER | January 2006 |
| | | |
| 2005 | | |
Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act (PDF - 116KB)
| CDER/CBER | September 2005 |
Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
| CDER/CBER | May 2005 |
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF version) (PDF - 342KB) (This document supersedes Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 29, 1998, and Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software, issued January 13, 1997.)
| CDRH/CBER | May 2005 |
Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF - 28KB)
| CDER/CBER | April 2005 |
Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB)
| CDER/CBER | April 2005 |
Guidance for Industry: Pharmacogenomic Data Submissions (PDF - 96KB)
| CDER/CBER/CDRH | March 2005 |
| | | |
| 2004 | | |
Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211KB)
| CDER/CBER | December 2004 |
Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA (PDF - 97KB)
| CBER/CDRH | November 2004 |
Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria (PDF - 175KB) (This document supersedes “Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria,” issued on October 4, 2004.)
| CDRH/CBER | October 2004 |
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) (PDF - 109KB) (This document supersedes “User Fees and Refunds for Premarket Notification Submissions (510(k)s)” dated May 28, 2004.)
| CDRH/CBER | May 2004 |
Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment (PDF - 515KB)
| CDRH/CBER | May 2004 |
| | | |
| 2003 | | |
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (PDF Version) (PDF - 87KB)
| CDRH/CBER | November 2003 |
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF - 159KB) (This document supersedes and replaces, “A Modular Approach to PMA Review,” dated January 29, 1998, and “Guidance for the Medical Device Industry on PMA Shell Development and Modular Review,” dated November 6, 1998)
| CDRH/CBER | November 2003 |
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)
| CBER/CDER/CDRH/CFSAN/CVM | October 2003 |
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 215KB)
| CDER/CBER/CDRH/CFSAN/CVM/ORA | August 2003 |
Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF - 529KB)
| CDRH/CBER | May 2003 |
Guidance for Industry and FDA Staff: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
| CDRH/CBER | February 2003 |
Draft Guidance for Industry: Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
| CDER/CBER/CVM | February 2003 |
Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews (PDF - 548KB) (This document supersedes the draft Guidance on Quality System Regulation Information for Various PreMarket Submissions released for comment on August 3, 1999)
| CDRH | February 2003 |
| | | |
| 2002 | | |
Guidance for Industry: Special Protocol Assessment (PDF - 36KB)
| CDER/CBER | May 2002 |
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF - 80KB)
| CBER | March 2002 |
| | | |
| 2001 | | |
Guidance for Industry: Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
| CDER/CBER | October 2001 |
Draft Guidance for Industry: Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF - 50KB)
| CDER/CBER | August 2001 |
Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF - 32KB)
| CDER/CBER/CVM | April 2001 |
Guidance for Industry: Acceptance of Foreign Clinical Studies (PDF - 12KB)
| CDER/CBER/CDRH | March 2001 |
| | | |
| 2000 | | |
Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB) (Withdrawn 10/3/2011)
| CDER/CBER | November 2000 |
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds (PDF - 26KB)
| CDER/CBER | October 2000 |
Guidance for Industry: Q & A - Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (PDF - 15KB)
| CDER/CBER | October 2000 |
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 31KB)
| CDER/CBER | February 2000 |
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level(PDF - 31KB)
| CDER/CBER | February 2000 |
| | | |
| 1999 | | |
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 50KB)
| CDER/CBER | Revised September 1999 |
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format — Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Applications (NDA)] (PDF 581KB)
| CBER | November 1999 |
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43KB)
| CDER/CBER | August 1999 |
| | | |
| 1998 | | |
Guidance for Industry: Advisory Committees Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 (PDF - 62KB)
| CDER/CBER | October 1998 |
Draft Guidance for Industry: Submitting Debarment Certification Statements (PDF - 144KB)
| CDER/CBER/CVM | September 1998 |
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements (PDF - 76KB)
| CDER/CBER | May 1998 |
Guidance for Industry: Classifying Resubmissions in Response to Action Letters (PDF - 76KB)
| CDER/CBER | April 1998 |
| | | |
| 1996 | | |
Guidance for Industry: The Content and Format for Pediatric Use Supplements
Center (PDF- 24KB)
| CDER/CBER | May 1996 |
| | | |
| 1995 | | |
Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products Center (PDF - 42KB)
| CDER/CBER | November 1995 |
| | | |
| 1994 | | |
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB)
| CBER/CVM | November 1994 |
| | | |
| 1991 | | |
| Guidance for Industry: Guideline on the Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB) | CDER | March 1991 |
| | | |
