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The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis and made available to patients sooner. Read More
Australian drug regulators have adopted their European counterparts’ definition of “commercially confidential information” — a move that is raising concerns among some drugmakers who contend that not enough consultation takes place with manufacturers to ascertain what constitutes CCI prior to its disclosure. Read More
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