FDA Issues Guidance Agenda for 2012
FDA has issued a list of planned draft and final guidance documents for release throughout 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
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