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
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
