CMC - NDA requirements and Common Pitfalls of BLAs (14of15) REdI – May 29-30, 2019

CDER Office of Pharmaceutical Quality’s Balajee Shanmugam and Steven Bowen discuss some of the common deficiencies encountered with Biologics License Application (BLA) submissions and provide guidance on how to avoid those pitfalls. A complete and accurate BLA is necessary for the marketing approval of new therapeutic biologics and biosimilar products. BLAs are frequently submitted to the FDA with unclear or missing information which can lead to information requests, post-marketing commitments, or complete responses.

Learn more at https://www.fda.gov/drugs/cder-small-...


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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.

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