...pre-marketing meetings, and IND information are being considered at FDA. The three-tiered guidance approach to jump-start the NDA/BLA review process was proposed at a recent FDA/industry workshop on CMC filings. The workshop focused on the challenges involved in refining a "rolling submission" system under which firms would submit "reviewable units" of CMC data to FDA prior to completion of the full NDA/BLA. In view of the workshop recommendations, FDA is also considering ways to make pre-marketing CMC meetings with industry more fruitful and to clarify IND filing requirements at Phase II/III.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
