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December 10 - 12, 2008 - Malvern, PA
This course provides comprehensive and up-to-date instruction on the preparation of an Abbreviated New Drug Application (ANDA) to the U.S. FDA Office of Generic Drugs, and is geared for those who assemble, supervise, or manage the preparation and submission of the ANDA. This course covers expectations regarding the format and content as described in FDA regulations and guidelines. Additionally, the course will cover preparation of paper-based and electronic submissions.
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This course provides comprehensive and up-to-date instruction on the preparation of an Abbreviated New Drug Application (ANDA) to the U.S. FDA Office of Generic Drugs, and is geared for those who assemble, supervise, or manage the preparation and submission of the ANDA. This course covers expectations regarding the format and content as described in FDA regulations and guidelines. Additionally, the course will cover preparation of paper-based and electronic submissions.
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