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Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements) – ResearchAndMarkets.com

The “Preparation
of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs,
ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)”
conference has been added to ResearchAndMarkets.com’s
offering.

Course “Preparation of FDA Submissions and Communicating with the FDA
(INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval
Supplements)” has been pre-approved by RAPS as eligible for up to 12
credits towards a participant’s RAC recertification upon full completion.

Why you should attend:

Upon completion of this course, attendees will have an understanding of
the framework for FDA submission regulations and an approach on how to
construct a submission. An appropriate submission strategy is necessary
to legally manufacture a product in the US market. The course focuses on
how a company’s product situation needs to be evaluated in order to
determine the correct interpretation of the submission requirements.
Emphasis will be placed not only on regulatory aspects, but on the
overall medical device and drug product development strategy and
environment. Creating an effective submission strategy will help your
company avoid spending unnecessary time and money by avoiding an
inappropriate path.

For more information about this conference visit https://www.researchandmarkets.com/research/22gfzw/preparation_of?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20180618006210/en/