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The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it. Read More
Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Read More
Three former Genentech employees were indicted by a federal grand jury for allegedly stealing trade secrets from the San Francisco-based Roche subsidiary, which is pursuing litigation of its own against the ex-staffers. Read More
Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) announced a bill that would update what they say are outdated drug labeling standards. Read More
The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure products. Read More
The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it will temporarily reduce or suspend more activities to save resources. Read More
Keystone Laboratories of Memphis, Tennessee, was hit with a consent decree ordering the company to stop selling over-the-counter drugs until it complies with current manufacturing practice requirements. Read More