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 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should be told if sponsors are worried experimental drugs may be triggering bad reactions, the FDA says in new draft guidance released Thursday.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
FDA Commissioner Scott Gottlieb announced Wednesday that the agency is hiring the National Academies of Sciences, Engineering and Medicine to help develop guidelines for opioid analgesic prescribing. Read More
The FDA is asking stakeholders to suggest structural endpoints for use in trials of medical products aimed at treating the root cause of osteoarthritis. Read More
The approval “represents a significant regulatory shift, with the approval received under unprecedented timelines,” said Sandra Horning, Roche’s chief medical officer and head of global product development. Read More