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.
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