FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are about 50 such guidances planned. Below are a few highlights for the drug-manufacturing space.
In biopharmaceutics and biosimilarity:
• Food-Effect Bioavailability and Fed Bioequivalence Studies— Bioavailability and Bioequivalence Studies for Orally
Administered Drug Products Submitted in New Drug Applications General Consideration
• Scientific Considerations in Demonstrating Biosimilarity To a Reference Product (draft already issued)
• Quality Considerations in Demonstrating Biosimilarity To a Reference Protein Product (draft already issued)
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
(draft already issued)
In combination products:
• Development of Drugs in Combination
Read more about FDA’s list of planned draft and final guidance documents for release throughout 2012 at PharmTech.com