FDA's new Guidance Documents for 2012

The  U.S. Food and Drug Administration FDA has issued its yearly list of planned draft and final guidance documents for 2012. There are about 50 such guidance documents planned.

This is an overview about some important ones:

Biopharmaceutics and Biosimilarity:

  • Scientific Considerations in Demonstrating Biosimilarity To a Reference Product 
  • Quality Considerations in Demonstrating Biosimilarity To a Reference Protein Product 

Combination Products:

  • Development of Drugs in Combination

cGMPs and Compliance:

  • Control of Highly Potent Compounds
  • Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs

Labeling, Packaging and Supply Chain:

  • Securing the Drug Supply Chain-Standards for Tracking and Tracing Prescription Drug Packages
  • Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling

Source: FDA Guidance Agenda

Compiled by
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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