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The FDA on Friday issued long-awaited guidance for large drug compounding facilities, clarifying the types of companies that must register with the agency, plus providing additional labeling guidance for repackaging activities and adverse event reporting requirements. Read More
Sponsors and investigators will share responsibilities for gathering and reporting clinical trial information on clinicaltrials.gov, if a November proposed rule is finalized. Read More
Experience levels of principal investigators fluctuate wildly the world over, a fact that could put promising research at risk, according to a Tufts University report on protocol noncompliance rates and principal investigator turnover. Read More
India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies — a continuation of the rebounding number of studies in the country. Read More
Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products.
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The House Energy & Commerce Committee, which oversees the FDA, is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight and give industry incentives to find new uses for old drugs. Read More
The drug pricing authority in India has published a compilation of the price caps for 509 drugs, effective Jan. 31, to give drugmakers a single source of pricing information. Read More