FDA guidances provide clarity on compounding exceptions

FDA released two draft guidance documents that provide clarity on the agency's thinking on sections 503A and 503B of the Food, Drug & Cosmetics Act, which restrict compounding of drugs that are essentially a copy of a commercially available

Read the full 390 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE