FDA’s Role and Compassionate Use: Senate Hearing Raises Old Questions In New Context
This article was originally published in RPM Report
FDA is subject to Congressional oversight from many different committees in the House and Senate. But Homeland Security isn’t usually one of them. Maybe that’s why some of the testimony felt about 15 years out of date.
You may also be interested in...
Sarepta's Eteplirsen Is Centerpiece Of Senate Hearing On Expanded Access
Witnesses call for political pressure on FDA to approve the Duchenne drug; patients and advocates also urge general approval reciprocity with Europe and incentives for pediatric trials; agency was not invited to testify.
Another Chance to Make Priority Review Vouchers Work
One of the “innovation” pieces of the FDA Safety & Innovation Act is a priority review voucher program for drugs to treat pediatric rare diseases. The new PRV is designed to avoid some of the glitches that have complicated the value of the program in tropical diseases—but it can’t avoid the core problem inherent in trying to capture the value of a priority review by legislative fiat.
Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation
Artificial intelligence model’s comments signal the likely start of computer-generated comments to the US FDA’s public notices.