FDA Office of Generic Drugs Question-Based Review Initiative: An Update

FDA Office of Generic Drugs Question-Based Review Initiative: An Update

May 29, 2009

Publication

Article

Pharmaceutical TechnologyPharmaceutical Technology-06-02-2009

Volume 33

Issue 6

The Question-Based Review (QbR) initiative of the Office of Generic Drugs has reached its second full year in 2009. Special from the Journal of Validation Technology.

This article was published in the Journal of Validation Technology, Spring 2009, Volume 15, Number 2. Authors Aloka Srinivasan and Robert Iser provide an update on the Question-Based Review Initiative by FDA's Office of Generic Drugs. Read about the initiative on gxpandjvt.com.

Articles in this issue

Quality in, Quality Out

Quarantine at a Glance

Drug Serialization and Supply-Chain Security

Initial Solvent Screening of Carbamazepine, Cimetidine, and Phenylbutazone: Part 2 of 2

Pharmacosomes: A Potential Alternative to Conventional Vesicular Systems

Package Design Boosts Patient Compliance

Truth and Transparency

Outsourcing Clinical Trial Materials

Penny-Wise, Pound-Foolish

Mapping Opportunities for Patent Positions

Beneath the Surface

Operator Error

Charting a Pathway to Follow-On Biologics

In the Spotlight June 2009

Report From: Ireland

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