FDA Evaluation of Psychedelic Medicines
The FDA is beginning to work with pharmaceutical companies on an approval pathway for psychedelic drugs that currently fall under Schedule 1 of the Controlled
The FDA is beginning to work with pharmaceutical companies on an approval pathway for psychedelic drugs that currently fall under Schedule 1 of the Controlled
“The Medicare trust fund cannot become a blank check for any drug or device manufacturer granted authorization by the FDA,” write authors of a Viewpoint
A proposed rule announced by the FDA to limit the nicotine concentration in combustible cigarettes ignores the delivery device used most commonly by youths: e-cigarettes.
The repercussions of the FDA’s accelerated approval of eteplirsen for Duchenne muscular dystrophy (DMD) in 2016 on the basis of a trial of 12 boys
“Continuation patents are becoming increasingly common in drug patent thickets, likely delaying or deterring generic competition, and thus potentially contributing to delays in patient access to
Products approved on an accelerated basis by FDA in 2009 through 2019 accounted for an inordinate amount of commerical health plan and enrollee out-of-pocket spending
Among indications of drugs approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2011–2020, the therapeutic value of
Because gene therapies are used to treat diseases affecting small numbers of patients, “they are approved by the [European Medicines Agency (EMA)] and FDA with
Americans could have access to a nonprescription, progestin-only oral contraceptive later this year if FDA follows the recommendation of an advisory committee. In a May
“Programmable [small interfering RNA (siRNA)] therapeutics have demonstrated effectiveness for treating an increasing number of rare conditions,” write authors of a review article. “The approach