Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry

August 11, 2017 -

Docket Number:

FDA-2017-D-2802

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” This draft guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to be documented in annual reports. Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that the Agency generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 10, 2017.

Read the full announcement: https://www.federalregister.gov/documents/2017/08/09/2017-16718/chemistry-manufacturing-and-controls-postapproval-manufacturing-changes-for-specified-biological

 

Disclaimer: The opinions expressed within this article are the views of the writer and do not necessarily reflect the views and opinions of ASME.


 
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