The role of the FDA in new drug development and availability.

During the last decade, the process by which the FDA regulates investigational new drugs has become a renewed focus of national attention. The ability of the FDA to maintain a balance between accelerating the availability of new drugs and ensuring that patients do not receive unsafe or ineffective treatments has been particularly challenged by the AIDS crisis. In response to this crisis, the FDA has revised its regulations and created various formal mechanisms for expediting the development and accessibility of promising new therapies to treat AIDS and other serious illnesses. Regulatory requirements have been reduced and consultation with the FDA to discuss the planning and design of clinical research is encouraged.