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Two GOP senators are sounding off on the FDA over an advisory committee recommendation against Sarepta’s Duchenne muscular dystrophy treatment eteplirsen. Read More
In an effort to lower prescription drug spending, China is slashing prices for three drugs by more than 50 percent, a move that will hit both GlaxoSmithKline and AstraZeneca in the wallet. Read More
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More
Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director Janet Woodcock. Tom Cosgrove, who until recently served as director of the OC’s Office of Manufacturing Quality, assumed her position on April 4. Read More
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Read More
Lunada Biomedical is barred from claiming that a dietary supplement can address perimenopausal and menopausal symptoms under a settlement agreement with the Federal Trade Commission. Read More
With clinical trial sponsors facing a slew of recruitment obstacles, one organization is recommending strategies to improve participation rates. Read More