Allows consumers to electronically report Web sites that may be illegally selling drugs, devices, dietary supplements, foods or cosmetics. The consumer reporting form, which is automatically submitted to the Office of Regulatory Affairs' enforcement division, applies to "problem" sites that do not involve life-threatening or serious reactions. ORA will investigate the sites and prosecute any that are unlawful. FDA is working with FTC and the Justice Department to investigate questionable sites and Internet sales practices
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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.
