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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specification-setting exercises to show how quickly the drug dissolves, the U.S. Food and Drug Administration says in draft guidance released July 31. Read More
The International Conference on Harmonisation is recommending that drugmakers limit their use of the solvent methylisobutylketone in drug products after two studies showed toxicity in rats and mice. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The European Medicines Agency issued draft guidance last month on the manufacture of finished dosage forms, clarifying the information drugmakers should include in the quality section of the common technical document in a premarket application. Read More
The European Medicines Agency is seeking feedback on draft guidelines on conditional approval and accelerated assessment as it strives to fast track medicines for unmet medical needs. Read More
Reports of adverse drug reactions in China rose by less than 1 percent last year, compared with 2013, with injectables showing the biggest increase, data released by the China Food and Drug Administration shows. Read More
The European Commission is suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data. Read More
The U.S. House of Representatives approved the 21st Century Cures Act by a vote of 344 to 77 on July 10, moving focus to the Senate where efforts are underway to develop comparable legislation. 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 U.S. Food and Drug Administration has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More