Registration Open: Live Webinars on Financial Incentives for CDER Medical Products; An FDA Perspective on the Bioanalytical Method Validation (BMV); and Identification of Medicinal Products (IDMP)

Financial Incentives For CDER Medical Products | June 10, 2019 Learn about FDA CDER economic assistance and economic incentives for drug development and maximize potential submission benefits. FDA will cover PDUFA waivers, reductions, and refunds; BsUFA fee structure and small business waivers; the Orphan Drug program; priority review vouchers; and exclusivity.

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Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care? | June 13, 2019 FDA subject matter experts will introduce the Identification of Medicinal Products (IDMP) initiative, scope, and benefits. They will also discuss FDA’s approach and challenges with the adoption of the five International Organization for Standardization (ISO) standards. The goals, objectives and timeframe for the development and implementation of the Global Substance Registration System’s (G-SRS) will also be covered.

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How should I measure this?  An FDA perspective on the Bioanalytical Method Validation (BMV) | June 17, 2019 This webinar provides an opportunity for FDA/CDER offices (Office of Generic Drugs (OGD), Office of Clinical Pharmacology (OCP) and Office of Study Integrity and Surveillance (OSIS)) to discuss how they use the 2018 Bioanalytical Method Validation (BMV) guidance and what FDA expects from the regulated industry.

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