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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specification-setting exercises to show how quickly the drug dissolves, the U.S. Food and Drug Administration says in draft guidance released July 31.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The European Medicines Agency issued draft guidance last month on the manufacture of finished dosage forms, clarifying the information drugmakers should include in the quality section of the common technical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
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
The European Medicines Agency is planning to develop an EU portal and database as a single entry point for clinical trial data submissions by May 2016. Read More