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Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
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specification-setting exercises to show how quickly the drug dissolves, the U.S. Food and Drug Administration says in draft guidance released July 31.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