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Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations

Generic drugmakers: You have until OCT. 1 to be GDUFA-ready. Help is at hand. Read this NOW.

For generic drugmakers, Oct. 1 is Crunch Time — the date after which all your ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012.

We’ve enlisted the assistance of Lachman Consulting’s Joan Janulis, a Hatch-Waxman pro and all-around expert on FDA regulation in the generic drug industry. She’ll help you read between the lines of the GDUFA performance metrics, associated guidance documents and MAPPs, and provide a roadmap to the post-GDUFA paradigm.

But make no mistake: this session is about much more than theory and abstraction. You’ll discover concrete examples that illustrate what ANDA sponsors can expect — and must prepare for.

In 90 fast-paced minutes, Ms. Janulis takes you from the big picture to nuts-and-bolts implementation. Here’s a point-by-point summary of what she’ll cover:

• Understanding how overarching GDUFA performance goals relate to ANDA reviews
• Identifying ANDA applications not subject to statutorily prescribed performance goals and how the FDA will handle these
• Impact of ANDA amendments (not to be underestimated!)
• Strategic opportunities and concealed risks associated with GDUFA
• “Standard industry practices” that could trip you up in the new GDUFA era
• Show-and-tell based on Lachman Consultants’ experience that steer you to higher application success rates under the new guidances
• And much more

With time so short before GDUFA full implementation, every second of advance preparation pays off in faster drug approvals and fewer hassles. Don’t mess with the FDA … or your company’s well-being.