New FDA Guidance Documents in Calendar Year 2011
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On January 26, 2011 the FDA issued the Guidance Agenda: New & Revised Draft Guidances CDER plans on publishing during the calendar year 2011.
The document is structured in different categories. With regard to Current Good Manufacturing Practices (CGMPs)/Compliance a number of documents are listed. Some of them will be of high interest for industry, like:
- Contract Manufacturing
- Control of Highly Potent Compounds
- Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs
- Non-Penicillin Beta-Lactam Contamination
- Pharmaceutical Component Quality Control
- Compliance Policy Guide Section 490.200 for FDA Staff: Parametric Release - Drug Products Terminally Sterilized by Moist Heat
In the category "Chemistry" the FDA plans on developing among others the following Guidelines:
- CMC Postapproval Changes Reportable in an Annual Report and
- Comparability Protocols for Approved Drugs: CMC Information
Source: Federal Register and CDER Webpage
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