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

UsernamePublicRestriction
UsernamePublicRestriction

FDA ONCOLOGY DIVISION GAINS SIGN-OFF AUTHORITY TO APPROVE

Executive Summary

FDA ONCOLOGY DIVISION GAINS SIGN-OFF AUTHORITY TO APPROVE cancer drug applications. The delegation of authority was outlined in a May 29 memorandum from the Office of Drug Evaluation I to Gregory Burke, MD, director of the Division of Oncology and Pulmonary Drugs. "This memorandum documents our intention to delegate to you sign-off of action letters for NDAs for all remaining undelegated oncologic drug products, including new chemical entities." The delegation will be authorized in a future Federal Register notice. The memo adds that the change in authority "is subject to modification by memorandum or case-by-case discussion." Previously, all drugs under the umbrella of the Office of Drug Evaluation I had to be approved by the director, Robert Temple, MD, or his deputy director Paula Botstein, MD. Cancer drug final sign-off was also in the purview of Drug Evaluation I under that system. Pulmonary drug reviews will continue to require final sign-off by the director or deputy director of the office. The Pilot Drug Evaluation Staff, which reviews analgesics, anti-inflammatory drugs and drug abuse treatments, already has similar autonomy. The separate authority granted to those two areas presumably indicates that they are viewed by FDA management as efficient operations that do not require as much oversight. In the May 29 memo, Temple and Botstein praise the oncology division management as "a first rate staff" for having done "an exceptional job of evaluating oncology drugs and of focusing on aspects needing wider discussion." The memo notes that "expanded delegation is a reflection of our confidence in that performance and the belief and expectation that under your stewardship rigorous and timely review will continue." The delegation memo points out that the shift in sign-off authority does not mean that the office will be completely removed from the review of oncologic drugs. "As these products remain in the office's area of responsibility, it is our expectation that office level involvement in the development and evaluation of oncologic drugs will continue, particularly where there is need for resolution of difficult issues or where a decision could be viewed as controversial, novel (e.g., a new mechanism of action, such as an immune modifier), precedent setting for the center and/or affecting actions to be taken by other review divisions." The Office of Drug Evaluation I said that the change should not be viewed as meaning that office level review of cancer drug applications are duplicative or unnecessary. The office maintained that its review does not add significantly to a drug's total review time and that applications are usually in the office for only a few weeks to one month before they are approved. The memo adds that "when an oncologic NDA or effectiveness supplement action letter is signed, please provide a copy of the letter to ODE I, accompanied (for favorable letters) by the approvable or approved labeling and the draft SBA [summary basis of approval]." The office added: "Please also notify the office a day or two before approval of an NME [new molecular entity] or a potentially controversial turndown."
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS019291

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel