FDA Issues Guidance Agenda for 2012 - - BioPharm International

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FDA Issues Guidance Agenda for 2012


BioPharm Bulletin

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

In CGMPs and compliance:

  • Control of Highly Potent Compounds
  • Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
  • Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs

In labeling, packaging, and supply chain:

  • Naming, Labeling, and Packaging Practices to Reduce Medication Errors
  • Securing the Drug Supply Chain—Standards for Tracking and Tracing Prescription Drug Packages
  • Drug Names and Dosage Forms
  • Organ-Specific Warnings: Internal Analgesic, Antipyretic and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling of Products That Contain Acetaminophen
  • Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling

In regulatory filings (electronic):

  • Providing Regulatory Submissions in Electronic Format – General Considerations
  • Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
  • Providing Regulatory Submissions in Electronic Format – Study Data
  • Providing Regulatory Submissions in Electronic Format – Standardized Study Data
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Source: BioPharm Bulletin,
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