Drug, Device Makers Face Inconsistent Human Research Rules (1)

Drug and device companies that conduct clinical trials likely will have to comply with two sets of differing human subject protection requirements starting early next year.

The White House’s fall regulatory agenda, released Oct. 17, includes three items that relate to the Food and Drug Administration’s effort conform its human subject protection requirements with the Department of Health and Human Services’ recently revised protections, known as the Common Rule (45 C.F.R. 46). The agenda is a semiannual list of rules that federal agencies are pursuing.

The fall 2018 agenda entries on subject protection indicate the FDA now plans ...