RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Quality & Compliance: Demystifying CMC Regulatory Strategy for Biologics, Part 1

Quality & Compliance: Demystifying CMC Regulatory Strategy for Biologics, Part 1

Posted 01 September 2011

Owing to the Biologics Price Competition and Innovation Act of 2009 that permits the US Food and Drug Administration (FDA) to pursue an abbreviated market approval pathway for biologics, along with industry projections that biologics may represent one in every four newly commercialized drugs in the future, much attention is focused on this class of pharmaceutical products.

 

© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe