News

Article

FDA Issues Guidance Agenda for 2012

Author(s):

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.

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

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More