Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence скачать в хорошем качестве

Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence

FDA discusses an overview of common deficiencies found during the filing review and recommendations for best practices for submitting controlled correspondences and substantially complete ANDAs. Presenters: Bijal Patel, PharmD, BCPS Division of Filing Review, OGD | CDER Nnenna Nzelibe, PharmD, MPH, BCACP Division of Filing Review, OGD | CDER Learn more at: https://www.fda.gov/drugs/news-events... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.     Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367