The long-awaited, mutually-agreed upon 21st Century Cures bill has finally been set in motion to become law, as the House is scheduled to vote on the biomedical innovation legislation Nov. 30.
The Evolution Of 21st Century Cures Legislation
Final version of Cures legislation combines several aspects of initial House and Senate legislation, and also includes some completely new elements.
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The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.