FDA Issues Guidance Agenda for 2012

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