List of Contributions

Can anyone offer an example or a guide on how to do an overall summary (Module 2.2) for an NDA? I never complete one, and I'm lost. This is for a college project. I will appreciate any guidance. ------------------------------ Charlotte, NC ------------------------------

Thank you so much for your advice ------------------------------ Charlotte, NC ------------------------------

Imagine this scenario:   A company is contractually obligated, through the purchase of a marketed product developed by another company, if no longer willing or able to commercialize the product, to immediately cease ALL activity related to that product.  This includes closing down any and all post-market ...

At what point in a product's life cycle would you find it appropriate to submit the same and/or similar dossier to Health Authorities ex-US?  Are there any gating factors you can think of?  What would be the "priority" list of countries to enter for global expansion? ------------------------------ ...

​After marketing a medical device in France what other EU Member State (s) the product can be distributed? Does anyone know the regulatory fee? ------------------------------ Brenda Miller Quality Assurance ------------------------------