| Title | Organization | Date |
|---|
| 2013 | | |
|---|
Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (PDF - 131KB) | CDER/CBER/CDRH | January
2013 |
| | | |
| Guidance for Industry: E3 Structure and Content of Clinical Study Reports Questions and Answers (R1) | CDER/CBER | January
2013 |
| | | |
| 2012 | | |
| | | |
| Draft Guidance Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products | CDER/CBER/CDRH | December 2012 |
| | | |
| Draft Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB | CDER/CBER/CDRH/OGCP | June 2012 |
| | | |
| Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND - Frequently Asked Questions (PDF - 109KB) | CDER/CBER | March 2012 |
| | | |
| Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers (PDF - 103KB) | CDER/CBER | February 2012 |
| | | |
| Draft Guidance for Industry: Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (PDF - 304KB) | CDER/CBER | February 2012 |
| | | |
|
| 2011 | | |
|---|
| | | |
| Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations | CDRH/CBER | November 2011 |
| | | |
| Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (PDF - 222KB) | CDER/CBER | June 2011 |
| | | |
| Draft Guidance for Industry and FDA Staff: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 316KB) | CDER/CBER | February 2011 |
| | | |
| 2010 | | |
|---|
| | | |
| Draft Guidance for Industry on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application (PDF - 210KB) | CDER/CBER | October 2010 |
| | | |
| Final Guidance for Industry and Researchers: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 417KB) | CDER/CBER | August 2010 |
| | | |
| Guidance for Industry: Lupus Nephritis Caused By Systemic Lupus Erythematosus — Developing Medical Products for Treatment (This guidance has been withdrawn) | CDER/CBER/CDRH | June 2010 |
| | | |
| Draft Guidance for Industry Non-Inferiority Clinical Trials (PDF - 565KB) | CDER/CBER | March 2010 |
| | | |
| Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 424KB | CDER/CBER | February 2010 |
| | | |
| Final Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF - 388KB) | CDRH/CBER | February 2010 |
| | | |
| 2009 | | |
| | | |
| Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB) | CDER/CBER | July 2009 |
| | | |
| Draft Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (PDF - 173KB) | CDER/CBER | July 2009 |
| | | |
Draft Guidance for Industry
and Researchers: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 421KB) | CDER/CBER | June 2009 |
| | | |
| Draft Guidance for Industry: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB) | CDER/CBER | January 2009 |
| | | |
| Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection (PDF - 61KB) | OC/CDER/CBER/CDRH/GCPP | January 2009 |
| | | |
| Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF - 180KB) | | |
| | | |
| 2007 | | |
| | | |
| Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145KB) | CDER/CBER | May 2007 |
| | | |
| Guidance for Industry: Computerized Systems Used in Clinical Trials (PDF - 53KB) | FDA/OC | May 2007 |
| | | |
| 2006 | | |
| | | |
| Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) (PDF - 127KB) | CDRH/CBER | October 2006 |
| | | |
| Final Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF - 196KB) | CDRH | July 2006 |
| | | |
| Guidance for Industry and FDA Staff Real-Time Premarket Approval Application (PMA) Supplements (PDF - 82KB) | CDRH/CBER | April 2006 |
| | | |
| Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB) | | January 2006 |
| | | |
| 2005 | | |
| Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF - 342KB) | CDRH/CBER | May 2005 |
| | | |
| 2004 | | |
| Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use | CDRH/CBER | November 2004 |
| Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA (PDF - 97KB) | CDRH/CBER | November 2004 |
| | | |
| Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF - 389KB) | 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 |
| | | |
| 2001 | | |
| FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB) | | November 2001 |
| | | |
| 2000 | | |
| | | |
| Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB) | CDER/CBER | October 2000 |
| | | |
| 1999 | | |
| Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44KB) | CDER/CBER | November 1999 |
| | | |
| Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB) | CDER/CBER/CDRH | July 1999 |
| | | |
| Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369KB) | CDER/CBER/CDRH | February 1999 |
| | | |
| Guidance for Industry: Population Pharmacokinetics (PDF - 135KB) | CDER/CBER | February 1999 |
| | | |
| 1998 | | |
| Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF - 37KB) | CDER/CBER | November 1998 |
| | | |
| Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129KB) | CDER/CBER | May 1998 |
| | | |
| Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 128KB) | CDER/CBER | May 1998 |
| | | |
| 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 (PDF - 42KB) | CDER/CBER | November 1995 |
