Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

FDA GENERIC DRUG GROUP ADDING ANDA REVIEW BRANCH IV to its ranks, bringing the total number of generic drug review branches to five -- four chemistry review branches and one antibiotic branch. A "vacancy announcement" for supervisory chemist of the new branch was posted by FDA Feb. 16 with a closing date of March 1. The agency reportedly intends to hire five review chemists to work in the new generic review branch. Additional recruitment efforts in the generic drug group include the hiring of two new review chemists, Abraham Croitoru and Paul Schwartz, who joined ANDA Review Branch 1 on Feb. 26. The additional review branch is expected to help reduce the backlog of ANDA applications that has been accumulating over the past several months as a result of the generic drug investigation. Recently, the rate of ANDA approvals has come to a near standstill. For example, the agency only approved one ANDA in February, compared to its monthly average of 40-50 prior to the investigation. According to the Office of Generic Drugs, an additional 30 FTEs (full time equivalents) have been allotted to the office for fiscal year 1990. The office says it is "vigorously pursuing recruitment" of new personnel in order to keep up with the growing number of pending ANDAs and supplements. Positions that are open include a director for the office of generic drugs, director of the generic drugs division, consumer safety officers, kineticists, review chemists and support staff. The agency is taking steps to make reviews more fair and efficient in response to recommendations made by the HHS Office of the Inspector General after its audit of the generic review process last summer. The IG had suggested that the agency develop "uniform review procedures and operating guidelines for assigning, reassigning, reviewing and tracking" applications in an efffort to reduce the possibility or appearance of favoritism ("The Pink Sheet" Aug. 28, p. 3). * One area the agency is working on is development of an ANDA review plan that would be modeled in part after the NDA approval process. The agency is considering dividing its ANDA review branches by therapeutic classification and assigning ANDAs to branch reviewers accordingly. At this time, the review branches are not formally organized by classification. Instead, ANDA applications often are assigned to reviewers who have historically handled the particular drug type that is the subject of the application.

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




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts