ANDA BACKLOG WILL BE TACKLED BY FDA NEW DRUG DIVISION CHEMISTRY REVIEWERS
Executive Summary
ANDA BACKLOG WILL BE TACKLED BY FDA NEW DRUG DIVISION CHEMISTRY REVIEWERS under a plan developed by FDA last week. According to the plan, the FDA Office of Generic Drugs will select 50-60 pending original ANDAs over the next two months and distribute them to NDA chemist reviewers, who will complete reviews of the chemistry portion of the applications. The ANDAs will then be sent back to the Division of Generic Drugs for further review. Each of the chemists in the nine NDA review divisions will be assigned an ANDA, which could take from four to 15 days to review. The chemists have been asked to contribute 20 hours of overtime per pay period to the effort. NDA review chemists assigned to the Generics division in April ("The Pink Sheet" April 30, T&G-1) will return to their divisions to review ANDAs. FDA said that it will monitor what effect the plan will have on the progress of NDA reviews. The Division of Generic Drugs currently has a backlog of about 550 overdue original ANDAs, 1,100 pending original ANDAs and thousands of supplements.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: