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A quartet of GOP senators is criticizing the FDA for relying on draft guidances to implement policy instead of rulemaking, and is clamoring for answers on how long it takes the agency to finalize drafts. Read More
Failing to communicate with a sponsor in a timely manner or collect data from clinical sites may be signs that a CRO isn’t doing its job — and a sign that it’s time for the sponsor to find a new partner, experts say. Read More
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