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The Indian government is considering establishing a $78 million venture capital fund to offer loans to drug companies that are building or expanding manufacturing facilities. Read More
Drugmakers doing business in India should prepare for price caps on more drugs as the National Pharmaceutical Pricing Authority rushes to complete price fixes on 98 essential drugs. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by giving drugmakers targeted advice on postmarket study design. Read More
The U.S. Food and Drug Administration and European Medicines Agency will establish a joint patient engagement working group to share best practices on involving patients in drug development and monitoring. 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specification-setting exercises to show how quickly the drug dissolves, the U.S. Food and Drug Administration says in draft guidance released July 31.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The European Medicines Agency issued draft guidance last month on the manufacture of finished dosage forms, clarifying the information drugmakers should include in the quality section of the common technical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