FDA announces new ‘streamlined’ application for investigative drugs

The FDA has released a new application for investigative drugs that it says will cut the amount of time physicians spend filling out such requests, as part of a larger effort to “streamline” the process of providing medications still undergoing regulatory review to their patients with severe illness.The final Individual Patient Expanded Access Investigational New Drug Application can be used by physicians to request expanded access to investigational drugs for patients who suffer from serious or immediately life-threatening diseases, in the absence of any comparable or satisfactory alternative treatment. According to a statement released by FDA Commissioner Robert Califf, MD, the new form is one part of a larger effort to improve the process by which physicians request “compassionate use” of investigative drugs.