Biotech Firm Sues FDA, Saying Clinical Hold Provision Is Unconstitutional

摘要

A biotech company sued the FDA Nov. 7 contending that a provision of the Federal Food, Drug, and Cosmetic Act (FDCA) is unconstitutional in that “it delegates unfettered discretion to FDA to issue a clinical hold order for ‘such other’ extrastatutory ‘reasons as [FDA] may by regulation establish.