Expedite Your FDA Generic Drug Approval - Webinar CD/Transcript
Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time
There are several common mistakes in ANDA submissions that you can avoid to ensure speedy approval.
Learn what those mistakes are and what to do about them with the webinar CD and transcript set led by 30-year industry expert Dr. Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech.
He discusses the major changes occurring due to GDUFA … shares his experiences from working at the FDA … tells you what he's learned from hundreds of successful submissions of ANDAs … and finally, shows you how to avoid the 3 most common mistakes made in ANDA submissions — and ensure first pass approvals.
And that's just the beginning. You'll also get specific information and details regarding:
- GDUFA's impact on today’s ANDA applications and how sponsors can best respond
- How today’s 3-year approval window will become a 10-month period under FDA’s proposed plans
- Lesser known impacts from GDUFA: facility fees, DMF completeness assessments and more
- The best application strategies within your control — whether you're a large or small generic drug company, including:
- Making sure you’ve checked for any product-specific FDA guidances
- Assuring you’ve adequately addressed bioequivalence requirements ahead of time
- Evaluating and documenting the inspection history of API and DP manufacturers (if applicable)
- Being confident you have ensured the complete, inclusive and full drug quality information in your ANDA application — including a thorough review of Module 2 against FDA’s QbR guidance
- Best practices to ensure the best quality, most comprehensive ANDA submission
- How to meet the FDA's completeness, quality, and bioequivalence requirements
- Comprehensive list of relevant and recent FDA guidances, resources, presentations, and templates for the ANDA’s administrative, bioequivalence and CMC requirements
This is your chance to take away proven, winning strategies so your generic applications will never again have to be sent through endless FDA approval cycles.