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Newly Added Guidance Documents

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

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions

Annex 9: Tablet Friability General Chapter

Annex 10: Polyacrylamide Gel Electrophoresis General Chapter

International Conference on Harmonisation - Quality

 

 Draft 8/13/2009
Pharmaceutical Components at Risk for Melamine Contamination Current Good Manufacturing Practices (CGMPs)/Compliance Final 8/6/2009
E16 Genomic Biomarkers Related to Drug Response:Context, Structure, and Format of Qualification Submissions International Conference on Harmonisation - Efficacy Draft 7/30/2009
Drug-Induced Liver Injury: Premarketing Clinical Evaluation Drug Safety Final 7/29/2009
Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act Drug Safety Draft 7/15/2009
ANDAs: Impurities in Drug Substances Generics Final 7/15/2009
Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Over-the-Counter Final 7/13/2009
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting Chemistry Draft 7/13/2009

Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs
(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 Labeling Final 6/26/2009
Q8(R1) Pharmaceutical Development Revision 1

International Conference on Harmonisation - Quality

 

 Final 6/9/2009
Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events Procedural Final 6/8/2009
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application Clinical/Medical Draft 6/2/2009
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products Procedural Draft 6/2/2009
Providing Regulatory Submissions in Electronic Format –Drug Establishment Registration and Drug Listing Electronic Submissions Final 5/28/2009
Presenting Risk Information in Prescription Drug and Medical Device Promotion Advertising Draft 5/26/2009
Formal Meetings Between the FDA and Sponsors or Applicants Procedural Final 5/19/2009
Labeling OTC Human Drug Products; Small Entity Compliance Guide Over-the-Counter Final 5/12/2009
Label Comprehension Studies for Nonprescription Drug Products Over-the-Counter Draft 4/30/2009
Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document  Procedural Final 4/20/2009
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications Generics Draft 4/16/2009
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions International Conference on Harmonisation - Quality Final 4/7/2009
Q10 Pharmaceutical Quality System International Conference on Harmonisation - Quality Final 4/7/2009
    
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