Generics in the US: A Regulatory Primer on Filings and Recent Actions

8:30 am

Welcome and Overview of Generics

Chand Sishta, PhD, RAC, director, mature products, Global Regulatory Sciences, Bristol-Myers Sq

8:45 am

Business Strategies for Generics

• Environmental incentives and the business case for generics
• Industry suggestions for strategies to work around the backlog at OGD
• Authorized generics

Chand Sishta, PhD, RAC, director, mature products, Global Regulatory Sciences, Bristol-Myers Sq

9:30 am

Issues Surrounding Exclusivity & Settlement Agreements

• Review of Hatch Waxman Act
• Recent legislative action re: loopholes

Kurt Karst, JD, director, Hyman, Phelps & McNamara, P.C.
Leslie Sands, director, regulatory affairs, Lupin Pharmaceuticals, Inc.

10:30 am

Pay-to-Delay Agreements

• impact on the future
• impact for healthcare community/end users

Kurt Karst, JD, director, Hyman, Phelps & McNamara, P.C.

11:30 am

Facilitated Group Discussion

All faculty

1:00 pm

Submissions

• Interfacing with OGD
• Strategies for alleviating the backlog of pending applications
• Generic Drug User Fees
• Status Update from OGD

Leslie Sands, director, regulatory affairs, Lupin Pharmaceuticals, Inc.

1:45 pm

Complex generics, part 1

• Lessons learned on the unique difficulties with complex actives/products

Vincent Andolina, vice president, Auromedics Pharma LLC

3:00 pm

Complex generics, part 2

• Case studies: Enoxaparin

Vincent Andolina, vice president, Auromedics Pharma LLC

4:00 pm

Quality by Design for Generics

• FDA expectations

Lane Christensen, PhD, chemist, science staff, Immediate Office, Office of Generic Drugs, CDER, FDA