FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Announces Pilot Program for CMC Changes

Feb. 22, 2019

The FDA is seeking participants for a pilot program to help the agency define specific established conditions (ECs) for chemistry, manufacturing and controls in applications for NDAs, ANDAs and BLAs.

The agency’s 2015 draft guidance on reportable CMC changes for approved drugs and biologics defines ECs as describing “the product, manufacturing process, facilities and equipment, and elements of the associated control strategy…that assure process performance and quality of an approved product.”

The agency said it will accept nine requests sent before May 30 from applicants who intend to submit NDAs, ANDAs and BLAs that contain proposed “explicit” ECs — ones in which the EC or its reporting category, if modified, differ from requirements contained in regulations and guidance. The pilot is intended to give the agency experience in assessing explicit ECs without affecting user fee deadlines.

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