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Men taking valproate, a commonly prescribed antiepileptic, should be cautioned that the drug could increase the risk of neurodevelopmental disorders in their offspring by up to 50 percent compared to similar medications, according to the safety committee of the European Medicines Agency (EMA). Read More
Looking back at FY 2023, CDER’s Office of Compliance’s recently issued annual report shows the office issued 170 human drug warning letters and classified 264 recalls affecting 1,178 drugs. Read More
Recently introduced bicameral, bipartisan legislation could make it easier for competitors to enter the generic and biosimilar market by putting controls on patent thickets created by pharmaceutical companies. Read More
Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by University of California San Francisco (UCSF) researchers. Read More
The FDA has classified three recalls as Class I because use of the devices carries the potential of serious adverse health effects and death. Read More
After evaluating reports of suicidal thoughts or action in patients taking diabetes and weight loss drugs containing glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as Ozempic/Wegovy, Byetta, Trulicity and Rybelsus, the FDA says its preliminary evaluation has found no evidence of these adverse events. Read More
To address the ongoing U.S. shortages of Bicillin L-A, a drug used to treat syphilis, the FDA has temporarily approved French manufacturer Laboratoires Delbert to import 3.6 million units of Extencilline, (benzathine benzylpenicillin) a drug not approved by the FDA, but also used to treat syphilis. Read More
In two recently issued documents, the FDA tackled methods for requesting reconsideration of an ANDA decision and provided final guidance on evaluating the viral safety of biotechnology products. Read More