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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

FDA Looks at PACs for Biologics

Sep 15, 2017, 14:29 PM
News Source Link:
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm570441.pdf
RegulatoryNewsDate:
Sep 15, 2017, 13:40 PM

In early August, the U.S. FDA released the draft guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. This draft guidance provides recommendations to holders of biologics license applications for specified products regarding the types of minor changes that need to be documented in an annual report. In particular, the document outlines CMC controls for post-approval changes the Agency considers to have minimal adverse impact on product. Under current regulations, such minor changes must be documented in an annual report.

Comments are due Oct. 10.

regulatory-news-regions:
  • North America