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A federal appeals court has upheld a lower court ruling that allowed Lupin to manufacture a generic of one of ViiV Healthcare’s HIV therapies, while blocking Teva’s ANDA of a related drug. Read More
Drugs containing the antihistamine hydroxyzine should be taken at the lowest effective dose for the shortest possible time to minimize heart risks, a drug safety committee in the EU says. Read More
The FDA last week granted final approval to Mylan and Watson for generic versions of Pfizer’s blockbuster arthritis drug Celebrex, allowing the companies to share 180-day exclusivity with Teva. Read More
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