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HHS’ Office of Inspector General has added four new projects to its 2015 work plan, including the creation of a Medicare Part D oversight portfolio and a review of states’ reporting on Medicaid rebate collections. Read More
The FDA has issued draft guidance spelling out in detail how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
The European Medicines Agency is revising the way drugmakers conduct studies of drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
Pharma sponsorship of head-to-head trials comparing two drugs for the same indication may present a serious conflict of interest, a group of American and Italian researchers says. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
Sponsors should decrease their use of on-site monitoring in clinical trials in favor of more centralized, risk-based methods that can be largely conducted remotely, an expert says. Read More
Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Bayer Healthcare’s Essure female contraceptive is facing new FDA scrutiny in the wake of a citizen petition alleging data integrity breaches on the part of the manufacturer. Read More
While overall survival remains the desired endpoint in treating non-small cell lung cancer, progression-free survival may suffice as the primary endpoint, the FDA says. Read More