SANDOZ PHARMA PROCESS VALIDATION FAILURES DRAW FDA WARNING LETTER Feb. 1 stemming from agency inspections of the company's Basel, Switzerland facility from June 22-28 and Nov. 2-10. The Sandoz responses to the FDA-483 report dated July 5 and 7, Sept. 20 and Nov. 24 "lack sufficient detail, explanations, or documentation to adequately address all of the deviations during the June and November inspections," the warning letter states.
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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.
