To Free or Not to Free

August 25 2016

There is something rotten in the State of Denmark (a/k/a the FDA) but things are not quite as bad as they may have appeared to Hamlet when he gave his famous “to be or not to be” speech. Yes, there are many questions about what the FDA will and will not permit. And, unfortunately, the FDA does not always provide clear answers or, for that matter, any answers. Though what follows does not constitute legal advice, we wanted to try to bring some clarity to some important and practical issues based on our cumulative decades of FDA experience. Use this information as guideposts but, as always, please consult your own counsel to determine what your corporate policies should be and how to legally comply with the Deeming Regulation. Click the link to read more: