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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Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.