We teach business people who have responsibilities which involve the FDA and the pharmaceutical approval process. Our presentations target those particular subject areas which relevant to your function in the pharmaceutcial industry, by using practical legal examples of the FDA and the pharmaceutical approval process in the global marketplace. We have prepared presentation topics, and can custom design a learning program for you. If you are unsure as to your needs as to the FDA and the pharmaceutical approval process, we provide a low cost assessment to the extent that you require. If you have any questions, email us at mabel@wcu.edu |
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FDA and the Pharmaceutical Approval Process
We have published several articles in this area including "Patent Licensee Estoppel" and "Preclinical Studies and Fair Use of Patents." We have recently presented a paper "Statutory Marketing Exclusivity for the First Filer of an Approved Generic Drug Application and the Orange Book" and are researching "FDA Preemption of State Law" and "Generic Drug Development and Marketing." |