Generic Drug Labeling: Recommendations for High-Quality Submissions (4of28) Generic Drugs Forum 2020 скачать в хорошем качестве

Generic Drug Labeling: Recommendations for High-Quality Submissions (4of28) Generic Drugs Forum 2020

Rachel Goehe and Katherine Won from CDER’s Office of Generic Drugs, Office of Labeling Review provide an overview of the labeling review process. They also cover supply recommendations, guidance for ensuring high-quality labeling submissions, strategies to reduce the number of review cycles, and responses to most frequently asked labeling-related questions. 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 and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367