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South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
Japan’s Pharmaceuticals and Medical Devices Agency was quicker to approve more new drugs in 2014 than its U.S. and EU counterparts, according to a new study released by the Centre for Innovation in Regulatory Science. Read More
The FDA issued a notice today clarifying that any adverse event not included on a compounded drug’s labeling should be considered “unexpected” and reported to the agency. Read More
Manufacturers of new drugs and biologics, generics and biosimilars, as well as outsourcing facilities, will pay higher user fees for their applications starting Oct. 1, according to figures released Friday by the FDA. Read More
Baxter International is recalling one lot of IV solution over leakage, particulates and missing port protectors — the company’s eighth recall since December 2013 and the second in July. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released Friday. Read More