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

NDA REWRITE WILL REQUIRE REPORTING OF INCREASED FREQUENCY OF DRUG REACTIONS

Executive Summary

FDA's NDA reg rewrite stipulates that an observed increase in the frequency of adverse drug reactions should be reported to the agency, according to a Dec. 11 HHS press release announcing that Secty. Heckler had signed-off on the document. According to the HHS release, a "significant increase in frequency" of adverse drug reactions would trigger the reporting requirements in the revised regulations. The requirement represents an addition to the reg revision proposal developed by the agency. Under the agency's original proposal, NDA applicants would have been required to report fatal or life-threatening adverse events within 15 working days, and the remainder of events within 30 days. The agency is eliminating the 30 days reporting requirement while retaining the 15 day report. According to HHS, "reports of significant increase in frequency of reactions to a drug will be required as soon as they are observed. Reports of serious, unexpected reactions will continue to be required as soon as details are known, in all cases within 15 working days." HHS said reports of other reactions "will be required every three months for three years after approval, up from one year." The release noted some of the major changes that were addressed in the proposed reg, such as new drug approval on the basis of foreign clinical data, NDA application format, and resolution of differences between FDA and drug sponsors. For instance, the new NDA application will require more focused and better organized analyses of data and will also allow "simultaneous review by FDA's several disciplines (clinical, pharmacological, chemical, statistical and biopharmaceutical)." FDA will assess approvability of an application 180 days after it is received, HHS pointed out. The reg includes a new procedure for a meeting between FDA scientists and company representatives "to resolve differences when a drug appears unapprovable." HHS noted that "most of the NDA requirements will become effective 90 days after publication, with a transition period of up to one year for certain requirements."

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

UsernamePublicRestriction

Register

PS007622

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

Cancel