Expanding Patient Access to Investigational New Drugs

Expanding access to investigational drugs for treatment use: a policy analysis and legislative proposal.

New investigational drugs for androgenetic alopecia.

INTRODUCTION Androgenetic alopecia (AGA) is the most common form of hair loss, however current treatment options are limited and moderately effective. In the past few years, there has been an increased interest in deciphering the molecular mechanisms responsible for this disorder, which has opened the possibility of novel treatments that promise to not only stimulate hair growth, but also to in...

Expanding Patient Access to Quality Sleep Health Care through Telemedicine.

Journal of Clinical Sleep Medicine, Vol. 12, No. 2, 2016 In January the American Academy of Sleep Medicine (AASM) officially launched AASM SleepTM, a state-ofthe-art telemedicine platform that was designed specifically for the sleep field by the AASM. This milestone represents the dawn of a new era for sleep medicine. Through AASM SleepTM, the potential now exists for any patient in any state o...

Practical, legal, and ethical issues in expanded access to investigational drugs.

The Food and Drug Administration (FDA) reviews clinical-trial data for new drugs and determines whether the benefits of these drugs outweigh the risks.1 This requirement, legislated in 1962,2 raised the bar to approval and reduced the likelihood that new drugs would be ineffective or cause major health problems. Developing such data about investigational drugs takes time for the assessment of p...

New investigational drugs with single-agent activity in multiple myeloma

The treatment of multiple myeloma (MM) is rapidly evolving. In the United States, four drugs (panobinostat, ixazomib, daratumumab and elotuzumab) were approved for the treatment of MM in 2015. As a result of improved diagnosis and therapy, there has been a dramatic improvement in the outcome of MM in the last decade, probably more than any other malignancy. Numerous agents continue to be studie...