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First Cycle Approval of ANDAs: The Journey from Conception to Reality
Are you looking forward to a one cycle approval of your ANDA, now that GDUFA II is on its way? Well, we have news for you: it is a lot harder than you might think.
The good news — this webinar CD and transcript, presented by Dr. Aloka Srinivasan, former FDA Team Leader from Office of Generic Drugs, gives an overview of how you may want to organize your ANDA to make first cycle approval a reality.
Dr. Srinivasan will discuss the current challenges with first cycle approval of ANDAs and how to overcome those challenges by submitting quality applications in the first place.
You’ll get first-hand, practical information about the current standards for generic drugs based on the Generic Drug User Fee Act (GDUFA), the guidance documents published during GDUFA I, and these critical issues:
And then there’s the topic of complex generics. When you’re talking complex generics, well, the key word is indeed “complex”. This presentation will include discussion on interaction with FDA in the area of complex generics, including:
The bottom line: You need expert advice and guidance related to first cycle ANDA approvals and information regarding how to advance your complex generics, and that’s what you’ll get from this presentation.
Pharmaceutical companies and professionals looking to understand today’s increased US regulatory requirements for generic drug approvals in the US, the impact of the recent approval of GDUFA, and how to avoid deficiencies in your pivotal ANDA submission, particularly regarding the Quality and Bioavailability/Bioequivalence requirements. Including:
Aloka Srinivasan, Ph.D., Principal Consultant, PAREXEL
Aloka Srinivasan, Ph.D., is currently a Principal Consultant at PAREXEL International. Aloka has over 10 years of experience in FDA and other government agencies, performing scientific research and evaluating the chemistry, manufacturing, and control (CMC) sections of applications. Prior to joining PAREXEL, Aloka was a Team Leader in Office of Generic Drugs, FDA and instrumental in laying the foundation for a DMF (Type II) Review Division at CDER.
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