Clinical Trials Advisor

Drugmakers and the rest of the scientific community can and should benefit from the careful disclosure of FDA review data, including clinical trial reports that industry and the agency now keep closely guarded, FDA Commissioner Margaret Hamburg says.

Device companies will continue to develop products abroad as long as financial and regulatory conditions overseas are more favorable than in the U.S., warned experts at the Food & Drug Law Institute annual meeting in Washington, D.C.

Full clinical trial reports with raw data should be publicly available, but regulatory authorities must develop engagement and standards to ensure meta- and re-analyses of data are of high quality, a group of European regulators say.

As efforts to simplify informed consent documents come up short, researchers may need to rethink the utility of the informed consent process and better evaluate how prospective trial participants are actually making decisions to join or decline a research study, according to an expert.

Novartis is investigating allegations in an Indian parliamentary report that as many as 33 new drugs approved between January 2008 and October 2010 — roughly one a month — never underwent clinical trials.

Safety and efficacy data for Regeneron’s Arcalyst do not support an indication to prevent gout flares, an FDA advisory panel voted unanimously.

Drugmakers seeking approval for biologics trials in the EU must describe and justify their manufacturing processes and process controls, ideally with a flow chart of all steps, the European Medicines Agency (EMA) says.

Drug sponsors may be able to relax a bit about an upcoming jump in comparative effectiveness research (CER) and its effect on FDA decisions.

The Centers for Medicare & Medicaid Services (CMS) is sparing drug manufacturers and group purchasing organizations (GPO) from reporting payments made to doctors and hospitals in 2012, as the agency continues to lag behind deadlines for issuing final Sunshine Act regulations.

Knowing what documents and information the FDA has a right to access is key to having a positive good clinical practice (GCP) inspection and can help minimize your company’s regulatory risk, David Chesney told participants at a recent FDAnews webinar on organizing data and document archives in preparation for FDA inspections.

To boost biopharma innovation and U.S. competition in the sector, the FDA should incentivize precompetitive industry collaborations, promote public-private partnerships and wrap up integration of its information technology (IT) systems, a new Obama Administration report states.