RU-486 Review Focus On "Intended Use" Is Appropriate - Henney
FDA approval of the abortifacient mifepristone (RU-486) is appropriate provided that the drug is safe and effective for its intended use by pregnant women for termination of pregnancy, FDA Commissioner nominee Jane Henney, MD, told the Senate Labor & Human Resources Committee Aug. 24.
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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.’
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Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.