FDA Issues Guidance Agenda for 2012 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Guidance Agenda for 2012


ePT--the Electronic Newsletter of Pharmaceutical Technology

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

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
11%
Provide treatment for patients globally.
7%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here