CDER Manual of Policy and Procedures describes specific actions FDA review staff will take once a product has received “breakthrough therapy” designation, with an emphasis on more meetings, more frequently.
The Center for Drug Evaluation and Research’s internal procedures for managing investigational drugs and biologics holding “breakthrough therapy” designation emphasizes the heightened level of FDA interaction that sponsors can expect under the expedited pathway.
In a Manual of Policy and Procedures released July 29, CDER’s Office of New Drugs makes clear that frequent and clear lines of communication between FDA and a sponsor will...
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.
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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.
