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The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More
Drugmakers and patients can now access risk evaluation and mitigation strategies for FDA-approved drugs, thanks to an updated website launched by the FDA on June 17. Read More
The National Institutes of Health is working quickly to correct major lapses in its drug compounding unit so officials will be able to ask the FDA to register it as a cGMP manufacturing facility subject to periodic regulatory inspections. Read More
Merck & Co. has agreed to pay $5.9 million to settle a federal lawsuit claiming a former subsidiary promoted its pink eye drug for off-label uses. Read More
The FDA should implement a pharmacovigilance audit program for drugmakers like the one the EMA adopted in 2012, to reduce the risk of postmarketing adverse events, a quality expert says. Read More
The FDA issued final guidance today formally adopting the U.S. Pharmacopeia’s strict naming rules for drug containing salt-based active ingredients. Read More