| Title | Organization | Date |
|---|
| 2013 | | |
| | | |
| Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products to Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex | CDRH/CDER/CBER/CVM | March 2013 |
| | | |
Draft Guidance for Industry and Review Staff: Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling - Good Review Practice (PDF - 115KB) | CDER/CBER | February 2013 |
| | | |
| Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements (PDF - 527KB) (Federal Register Notice: February 25, 2013) | CDER/CBER | February 2013 |
| | | |
| 2012 | | |
| Draft Guidance for Industry: Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program | CDER/CBER | March 2012 |
| | | |
| Guidance for Industry Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 153KB) | CDER/CBER/CVM | January 2012 |
| | | |
| 2011 | | |
| Guidance for Industry: Bar Code Label Requirements - Questions and Answers (PDF - 72KB) | CDER/CBER | August 2011 |
| | | |
| 2010 | | |
| Guidance for Industry: Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (PDF - 163KB) | CDER/CBER | March 2010 |
| | | |
| Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB) | CDER/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 |
| | | |
| Final Guidance for Industry and Review Staff: Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 65KB) | CDER/CBER | October 2009 |
| | | |
| Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387KB) | CDER/CBER/CDRH/CVM | May 2009 |
| | | |
| 2008 | | |
| Final Guidance for Industry: Indexing Structured Product Labeling (PDF - 59KB) | CDER/CBER | June 2008 |
| | | |
| 2007 | | |
| Final Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version) (PDF - 139KB) | CDRH/CBER | September 2007 |
| | | |
| 2006 | | |
| Final Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 52KB) | CDER/CBER | January 2006 |
| | | |
| Final Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB) | CDER/CBER | January 2006 |
| | | |
| Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products —Content and Format(PDF - 58KB) | CDER/CBER | January 2006 |
| | | |
| 2005 | | |
| Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF - 28KB) | CDER/CBER | April 2005 |
| | | |
| Draft Guidance for Industry: Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB) | CDER/CBER | February 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 (PDF - 1385KB) | CDRH/CBER | November 2004 |
| | | |
| Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB) | CDER/CBER | January 2004 |
| | | |
| Draft Guidance for Industry: "Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (PDF - 188KB) | CDER/CBER/CDRH | January 2004 |
| | | |
| 2003 | | |
| Final Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222KB) | CDER/CBER | May 2003 |
| | | |
| 2001 | | |
| Final Guidance for Industry: Content and Format for Geriatric Labeling (PDF - 38KB) | CDER/CBER
| October 2001 |
| | | |
| Draft Guidance for Industry: Prescription Drug Advertising and Promotional Labeling (PDF - 28KB) | CDER/CBER
| January 2001 |
| | | |
| 1999 | | |
| Final 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 |
| | | |
| Final Guidance for Industry: Consumer-Directed Broadcast Advertisements (PDF - 36KB) | CDER/CBER/CVM | August 1999 |
| | | |
| Draft Guidance for Industry: Accelerated Approval Products —Submission of Promotional Materials (PDF - 17KB) | CDER/CBER | March 1999 |
| | | |
| Draft Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB) | CDER/CBER/CVM | January 1999 |
| | | |
| 1998 | | |
| Final Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979KB) | CDER/CBER | July 1998 |
| | | |
