FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products- June 10, 2019 Published 2020-02-06 Download video MP4 360p Download video MP4 720p Recommendations 47:50 Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My- June 10, 2019 46:00 Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017 1:13:26 Current Global Generic Drug Landscape (10of16) Generic Drugs Forum 38:21 NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019 28:12 Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD 20:14 Generic Drug Product Quality Assessment (22of27) Generic Drugs Forum 2018 29:03 Drug Master File (DMF) Submissions on New FDA Form 3938 35:51 Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN 02:02 5 Things You Need to Know About the Drug Approval Process 1:00:50 CDER FDA Exclusivity – Which One Is for Me? - June 10, 2019 57:39 Study Data Standards Update for CBER: Your Guide to a Successful Submission 1:30:38 Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations 1:40:14 Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 – Session 3 06:14 A Day in the Life of an Import Investigator 00:26 ¿Sabes que los medicamentos de fórmulas magistrales no están aprobados por la FDA? #DatosDeLaFDA 5:36:30 April 28, 2023 Meeting of the Oncologic Drugs Advisory Committee (ODAC) 06:05 Episode 3 - On The Road with Jim Jones - Jan 2024 04:50 A Conversation With Janet Woodcock, M.D. and Namandjé Bumpus, Ph.D. 7:06:50 FDA-MHRA-HC 2024 Joint Symposium (Day 1) 6:35:12 Meeting of the Oncologic Drugs Advisory Committee (ODAC) Similar videos 17:56 Panel on Financial Incentives FDA Orphan Drugs Program and Priority Review Vouchers - June 10, 2019 24:07 Panel on Financial Incentives for CDER Medical Products - PDUFA & Biosimilars - June 10, 2019 03:18 What are Orphan Medicines? - Video explainer 27:20 How to apply and benefit from an Orphan Drug Designation 03:27 FDA Incentives to Promote Rare Disease Drug Development 03:17 A New FDA-Approved Gene Therapy Helps Treat a Rare Childhood Cancer 08:40 GDUFA 04:45 Patients Matter: FDA’s Office of Orphan Products Development Grants Programs 07:53 Orphan Drug Development | Episode 06 - USFDA vs EMA : Orphan Drug Designation | Regulatory Affairs 01:45 Orphan Drug, Rare Pediatric Disease, and Expedited Program Designations Webinar (10/6) 36:06 What can CDER do for you? (3of15) REdI Annual Conference – May 29-30, 2019 01:15 What Is "Orphan Drug Status?" 1:04:34 A Regulatory & Strategic Framework for Facilitating Pediatric Drug Development 50:17 What Everyone Affected by a Rare Disease Should Know About the Orphan Drug Act 01:29 Orphan Drug Incentives From the FDA 02:04 5 Myths About Orphan Drugs and the Orphan Drug Act 07:33 The patients priced out of orphan drugs - BBC Newsnight More results