Offering extended exclusivity, in advance, for drugs that address an unmet medical need could bring a necessary boost to research and development efforts, Vanderbilt University's Alastair Wood said

Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.

A draft agreement between industry and FDA that would assess user fees for "advisory review" of broadcast direct-to-consumer ads prior to initial public dissemination had its genesis in the Pharmaceutical Research & Manufacturers of America's DTC guiding principles