Generic Drug Super Office Takes Shape - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Generic Drug Super Office Takes Shape



The Office of Generic Drugs (OGD) is readying for its shift to a larger and more complex organization on par with offices for new drugs, drug safety, and compliance in FDA’s Center for Drug Evaluation and Research (CDER). Under the new generic drug user fee program (GDUFA), OGD is expanding its staff, working through a massive backlog of abbreviated new drug applications (ANDAs) and prior approval supplements, and assessing the completeness of drug master files in addition to evaluating more ANDAs and supplements.

The expanded OGD will have a strong clinical presence to assess bioequivalence and other tests, explained OGD acting director Kathleen Uhl at the Generic Pharmaceutical Association’s technical conference in October. An office of research will carry out studies to support development of more complex generic dosage forms, while an office of generic drug policy will develop guidance and internal procedures, Uhl noted. Chemists and microbiologists will join the new Office of Pharmaceutical Quality (OPQ), when it is established next year to unify the oversight of manufacturing and quality performance for all drugs, including biotech therapies.  

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here