generic drug product development

0:54:12

Best Practices for Topical Generic Product Development and ANDA Submission – Session 2

1:38:58

Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 1

1:12:08

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 2

0:12:57

Product Specific Guidances Webinar – Opening Remarks

0:50:54

Model-Integrated Evidence for Generic Drug Development – Session 1A

3:01:55

Facilitating Generic Drug Product Development through Product-Specific Guidances

0:35:52

Pre-ANDA Interactions with the FDA (6of16) Generic Drugs Forum 2020

1:31:24

Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 2

1:54:43

Advancing Generic Drug Development Translating Science to Approval Day 1–Session 4 & Closing Remarks

1:47:25

Considerations in Assessing Generic Drug Products of Oral Dosage Forms

2:28:46

Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 2

0:09:06

Advancing Generic Drug Development: Translating Science to Approval Keynote Address

0:06:06

Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks

0:35:01

Combination Products: User-interface & Role of Comparative Analyses (29of39) Complex Generics 2018

0:15:08

Product Dev Considerations for Generic Transdermal Delivery Systems (26of39) Complex Generics 2018

0:19:07

BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019

0:08:26

Dr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020

0:22:03

Quality View on Injectable Product Considerations (20of35) Complex Generic Drugs – Sep. 25-26, 2019

0:19:08

Generic Topical and Transdermal Products (5of35) Complex Generics– Sep. 25-26, 2019

0:15:05

Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24of35) Complex Generics – Sep. 25-26, 2019

0:59:10

FDA (CDER): Generic Development and Bridging Global Regulations

0:06:07

Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks

1:01:02

Model-Integrated Evidence for Generic Drug Development – Session 1C

0:47:39

New Programs and Requirements Under FDARA (5of16) Generic Drugs Forum 2020