First Cycle Approval of ANDAs - Webinar CD/Transcript

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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:

  • Changes in requirements for Type II DMFs, promulgated by FDA, based on GDUFA
  • Changes in requirements for ANDAs, promulgated by FDA, based on GDUFA
  • What the generic industry would like to be the focus of GDUFA II

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:

  • Complex generics and the challenges facing the industry
  • The best ways to move forward
  • The best ways to communicate with OGD
  • The best ways to prepare for meetings with FDA, if granted

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:

  • Submission and applications specialist
  • Strategic planning and lifecycle management specialists
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry
  • Regulatory professionals
  • Consultants/service providers

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.