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- FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymakingJournal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…BioSpace · 12d ago↗ source
- Experts: Ending adequate provision would shut down prescription drug adsThe US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the hig…raps · 13d ago↗ source
- Industry wants more clarity on NGS for assessing gene therapy safetyThe pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…