Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.
|
Title and Format
|
Subject
|
Type
|
Issue Date
|
|
Dosage Delivery Devices for OTC Liquid Drug Products (PDF -93 KB)
|
Current Good Manufacturing Practices (CGMPs)/Compliance |
Draft |
11/04/2009 |
| SPL Standard for Content of Labeling Technical Qs & As (PDF - 56 KB) |
Electronic Submissions |
Draft |
10/27/2009 |
| Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163 KB) |
Procedural |
Final |
10/23/2009 |
| Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 66 KB) |
Labeling |
Final |
10/16/2009 |
| Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (PDF - 145 KB) |
Clinical/Antimicrobial |
Draft |
10/2/2009 |
| Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (PDF - 316 KB) |
Drug Safety |
Draft |
9/30/2009 |
| End-of-Phase 2A Meetings (PDF - 163 KB) |
Procedural |
Final |
9/18/2009 |
| Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF - 272 KB) |
Clinical/ Antimicrobial |
Draft |
9/16/2009 |
| Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers (PDF - 84 KB) |
Over-The-Counter |
Final |
8/31/2009 |
|
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions
Annex 9: Tablet Friability General Chapter (PDF - 86 KB)
Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 92 KB)
|
International Conference on Harmonisation - Quality |
Draft |
8/13/2009 |
| Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137 KB) |
Current Good Manufacturing Practices (CGMPs)/Compliance |
Final |
8/6/2009 |
| E16 Genomic Biomarkers Related to Drug Response:Context, Structure, and Format of Qualification Submissions (PDF - 135 KB) |
International Conference on Harmonisation - Efficacy |
Draft |
7/30/2009 |
| Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206 KB) |
Drug Safety |
Final |
7/29/2009 |
| Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (PDF - 173 KB) |
Drug Safety |
Draft |
7/15/2009 |
| ANDAs: Impurities in Drug Substances (PDF - 136 KB) |
Generics |
Final |
7/15/2009 |
| Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (PDF - 298 KB) |
Over-the-Counter |
Final |
7/13/2009 |
| Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 79 KB) |
Chemistry |
Draft |
7/13/2009 |
|
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (PDF - 32 KB)
(Level 2 guidance on Penicillin Drugs added)
|
Current Good Manufacturing Practice (CGMP's)/Compliance |
Final |
6/29/2009 |
| Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (PDF - 188 KB) |
Labeling |
Final |
6/26/2009 |
| Q8(R1) Pharmaceutical Development Revision 1 (PDF - 336 KB) |
International Conference on Harmonisation - Quality
|
Final |
6/9/2009 |
| Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events (PDF - 67 KB) |
Procedural |
Final |
6/8/2009 |
| The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 421 KB) |
Clinical/Medical |
Draft |
6/2/2009 |
| Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products (PDF - 112 KB) |
Procedural |
Draft |
6/2/2009 |
| Providing Regulatory Submissions in Electronic Format –Drug Establishment Registration and Drug Listing (PDF - 123 KB) |
Electronic Submissions |
Final |
5/28/2009 |
| Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387 KB) |
Advertising |
Draft |
5/26/2009 |
| Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89 KB) |
Procedural |
Final |
5/19/2009 |
| Labeling OTC Human Drug Products; Small Entity Compliance Guide (PDF - 270 KB) |
Over-the-Counter |
Final |
5/12/2009 |
