FDA Provides Answers to Biologics License Questions
A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
FDA issued a Q&A document on March 4, 2020 that answers questions about the implementation of the transition of biologics applications from approval under the Federal Food, Drug, and Cosmetic (FD&C) Act to section 351 of the Public Health Service (PHS) Act. The transition is part of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and will begin on March 23, 2020.
Specifically, the document describes the types of products affected by the transition and provides information about application and license numbers; agency office review procedures; chemistry, manufacturing, and control changes; and other requirements. The agency also describes the labeling compliance policy for biologics license applications.
Source: FDA
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
