FDA Guidance Documents & FAQs
The FDA is accepting comments on the following new draft guidance documents for industry:
- Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting; to be considered in drafting the final guidance, comments must be received by October 13, 2009.
- Postmarketing Studies and Clinical Trials— Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act; comments are due October 13, 2009.
In addition, the FDA recently has issued a number of final guidance documents and “frequently asked question” documents, including the following:
- Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.
- Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
- Frequently Asked Questions: Institutional Review Board Registration.
- Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances (Revision 1).
