FDA OASIS IMPORT AUTOMATION SYSTEM TO ROLL-OUT NATIONALLY IN AUGUST 1996 in phases expanding the use of the agency's Operational and Administrative System for Import Support. FDA indicated that the roll-out will take place after the current software contractor, Booz Allen Hamilton, completes re-engineering of the OASIS data base. The data base re-engineering is scheduled for completion by July 31, 1996.
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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.
