James A. Boiani
James Boiani, Senior Counsel in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled “Six Steps to Overcome a Negative FDA Review.”
Following is an excerpt:
You have spent three years working on an NDA, waited patiently through the FDA review, and just received FDA’s decision. It’s not good — FDA has found several problems and is sending you back to the drawing board. It looks like you’re not getting approved anytime soon.
If you have enough money and time, maybe you do everything FDA requested. For many companies, though, that’s not an option. What do you do?