FDA Issues Draft Guidance on Biologic License Applications

The FDA recently released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the minor changes that should be documented in an annual report. As the number of chemistry, manufacturing and controls (CMC) postapproval manufacture supplements continue to increase, the FDA decided to publish this guidance. Guidance This guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA generally consider to have a minimal potential to have an adverse effect on product quality. Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report. Recommendations for Reporting Certain Changes in an Annual Report FDA recommends that the changes listed in the Appendix generally should be submitted in an annual report. However, if a BLA holder is planning to make a change that is listed in the Appendix, the BLA holder should evaluate the change in the context of the holder’s particular circumstances to determine whether the proposed change would present a minima...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs