We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A coalition of health care stakeholders called on the FDA to issue final guidance on interchangeable biosimilars to help promote drug price competition, saying the agency’s failure to finalize its January 2017 draft guidance created “significant uncertainty.” Read More
Excluding certain patients “limits the ability of a trial to generate data that are relevant to the actual users of the drug,” the experts said. Read More
According to the DOJ, the two doctors distributed or prescribed controlled substances such as Oxycodone, Percocet and steroids illegally to undercover agents. Read More
A panel of experts is urging the FDA to reconsider rigid rules excluding certain groups from clinical trials — or at least make decisions on a case-by-case basis. Read More
In its latest move to combat opioid abuse, the Justice Department slapped two Ohio doctors with restraining orders after a sting operation found they illegally prescribed opioid painkillers and other drugs. Read More
An appeals court Wednesday overturned a federal court ruling that GlaxoSmithKline was liable for the suicide of an attorney who took a generic of its antidepressant drug Paxil (paroxetine). Read More
Cancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse—and patients and researchers should be told if sponsors are worried experimental drugs may be triggering bad reactions, the FDA says in new draft guidance released Thursday. Read More