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FDA to Share Perspective on Polymorphic Forms in Abbreviated New Drug Applications (ANDAs)

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FDA to Share Perspective on Polymorphic Forms in Abbreviated New Drug Applications (ANDAs)

Written by Toby Cobbledick

Friday, 21 November 2008

The FDA will make a presentation on ANDA's at the IQPC Polymorphism & Crystallisation Conference 2009

The FDA have confirmed they will be providing an insight into Polymorphic Forms in Abbreviated New Drug Applications (ANDAs).

Andre Raw, Ph.D, Senior Regulatory Chemist at the Office of Generic Drugs, based at the Centre of Drug Evaluation and Research (CDER) will be delivering the information via a presentation at the 6^th annual IQPC Polymorphism & Crystallisation conference which takes place 11-13^th March 2009 in London.

Dr. Raw will address the scientific considerations of polymorphism to drug product safety, efficacy and quality; as well as those considerations of polymorphism applicable to drug product formulation and process design.

Delegates will be provided with an overview of regulatory considerations of polymorphism in ANDA’s as well as looking in more detail at question based review and interlinking regulatory considerations of polymorphism to pharmaceutical Quality by Design in ANDAs.

Sarah Haynes, Event Director at Pharma IQ responded to the confirmation saying “This is a great opportunity for the FDA to answer the attendees’ most important questions. Having an official onsite is a rarity at any European conference and I am sure that this will make for interesting and varied discussion. It will certainly help support the event’s aim to allow participants to take home essential practical advice and guidance.”

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