Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)
June 7, 2013 - Palo Alto CA US

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Areas Covered in the Webinar: Strategic Planning for an ANDA vs Paragraph IV Efficient Implementation and Communication with the FDA. Content and Format of ANDA’s Plan for FDA-Sponsor Meetings FDA Expectations and CMC Data including Bioavailability/Bioequivalence Outline of Paragraph IV Applications and Case Studies Who will Benefit: This topic applies to personnel/ companies in the pharma/biopharma industries. The employees who will benefit most include: Senior management Regulatory affairs Quality Assurance CMC and Clinical Development Documentation Scientists, R&D Product Development

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