The CEO of the company plans to market the new patented design and formulation combination drug/device product (i.e. EpiPen) as soon as possible and meets with you for your recommendation for the best strategy.
One approach is to seek regulatory approval overseas (i.e. Europe, China, Australia, Canada) in order to facilitate approval for product on the market overseas prior to approval to market in the U.S.A. via US FDA. Another is to seek approval from US FDA for U.S.A. market prior marketing internationally.
As the regulatory head for this company, what steps should the company take to accomplish approval via US FDA, if you think this is the best first course of action prior approval within other countries? Otherwise if you think that approval/marketing overseas would cost considerably less and is the shortest pathway, what steps are taken to approve this product overseas first prior accomplishing US FDA approval for USA markets?
Include ICH s recommendations and regulatory steps within the country of your choice (Europe, China, Australia, or Canada) that include pre-clinical and clinical information. Can this information be applied towards US FDA applications, or do they have to be repeated?
Include the regulatory applications, adverse reporting requirements, and post-market surveillance.
There are no right or wrong answer for this strategy. The outcome is subsequent approval and marketing of this product within the global level. Expected length is 5 to 10 pages for this Research Paper.