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The FDA plans to ease requirements for trials of drugs aimed at treating hospital-acquired or ventilator-associated bacterial pneumonia, including allowing sponsors to enroll some subjects in trials before a confirmed diagnosis and easing restrictions on prior antibiotic use — both contentious limitations imposed in current guidance. Read More
The FDA says it will reach out to holders of roughly 375 prescription drug applications filed before June 2001 and ask them to voluntarily adopt the user-friendly labeling format created under the “Physician Labeling Rule.” Read More
Brand drugmakers have been enthusiastic supporters of the FDA’s plans to offer five years of market exclusivity for more fixed-dose combination products — but they want the agency to broaden its new policy so it will cover products already under review. Read More
Indian Cabinet Secretary Ajit Seth and other top Indian officials met last month to devise a framework for discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More
The FDA’s top drug official slammed the current clinical trial system as a major barrier to rapid drug development and urged the drug industry to adopt clinical trial networks as a better way to evaluate new products. Read More
A federal appeals court has ruled that generic manufacturers of Merck’s osteoporosis drug Fosamax cannot be held liable for “design defect” claims against the product. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More
European drug regulators saw a 30 percent increase in adverse drug reaction (ADR) reporting in the EU following the implementation of massive pharmacovigilance legislation in 2012. Read More
Longer-term clinical benefits associated with sustained soliris treatment include prevention of TMA and continued improvement in renal function. Read More