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Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12of15) REdI– May 29-30, 2019

Rachael Conklin, CDER Office of Medical Policy, covers the fundamentals of submitting promotional materials to Office of Prescription Drug Promotion (OPDP), with a particular focus on submissions occurring during the launch phase. She discusses accelerated approval submissions, press releases, annotations, electronic submissions, and resubmissions and/or amendments. Learn more at https://www.fda.gov/drugs/cder-small-... _______________________________ 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. Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367 LinkedIn:   / cder-small-business-and-industry-assistance   Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...