Trainings By Informa Markets in India
Informa


Reinventing The Wheel Through Super Generics With 505(b)(2)

Duration - 50 Minutes

About the course

Brief history of how 505(b)(2) NDA were created.
• Similarities and differences with 505(b)(1) NDA (innovator drugs) and 505 (j)(2) ANDA.
• What types of market exclusivities can be granted using the 505(b)(2) pathway.
• Critical requirements for FDA to accept a 505(b)(2) application for filing and review.
• What type of information is typically included in a 505(b)(2) NDA submission.
• Typical FDA review issues for 505(b)(2) applications.
• Compliance considerations (GXP) for 505(b)(2) submissions.

Speaker Profile

Phil Crooker

Vice President, Technical - Regulatory & Access
Parexel International and Former FDA