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Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More
The EU-based Innovative Medicines Initiative is launching a $4.5 billion decade-long effort to improve the success rate of clinical trials for certain drugs by 30 percent and boost exclusivity to entice sponsors to develop the drugs. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
Indian regulators have issued a uniform set of procedures that state drug authorities should follow when inspecting plants for good manufacturing practices and issuing certificates of pharmaceutical product (COPP) that clear drugs for export. Read More
The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers who claim “extraordinary hardship,” such as catastrophic incidents or abrupt supply disruption. Read More
Drugmakers Hoffman-La Roche and Hyperion Therapeutics are taking part in Health Canada’s new orphan drugs pilot project to better understand how patient input may be gathered and incorporated into the drug submission review process. Read More
Pfizer will pay $35 million divided among 41 states and the District of Columbia to settle allegations it improperly marketed its immunosuppressant Rapamune for unapproved uses, a year after making a $490.9 million deal with the federal government for similar allegations. Read More
Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders. Read More
The FDA has approved The Medicines Company’s intravenous skin disease treatment Orbactiv, the third such product cleared this year under a pathway that provides manufacturers incentives to develop new antibiotics for serious or life-threatening infections. Read More