USA – HHS proposes updates to patient labeling, BA/BE study regulation

The US Department of Health and Human Services (HHS) has released its semiannual inventory of proposed rulemaking actions, with a relatively brief to-do list for drug and medical device regulators.

For the US Food and Drug Administration (FDA), actions sitting at the proposed rule stage include an amendment to 21 CFR 320 to clarify FDA’s expectations for the conduct of analytical and clinical pharmacology as well as bioavailability and bioequivalence studies to support marketing applications for drugs and biologics. The proposed rule would also debut 21 CFR 321 to address details of these issues.

“The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies,” according to HHS. The goal for this action would be to achieve better international regulatory harmonization as well as alignment with other FDA regulations and industry practice…