Ethics/Regulatory

AB Science warned about putting study volunteers in danger

Monday, July 27, 2015

The FDA’s Office of Scientific Investigations has issued a warning letter to Paris-based AB Science, a pharmaceutical company that targets cancer and other diseases with high unmet medical need, for compromising the safety of study participants by failing to properly monitor its clinical trials and ensure investigators follow protocol requirements.

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FDA selects eight new patient groups for input

Monday, July 20, 2015

The FDA released a list of eight new conditions that it plans to assess during the next two years as part of its Patient-Focused Drug Development (PFDD) program. The program seeks to inform regulatory decision-making by soliciting patients’ perspectives on their diseases, treatment options and preferred endpoints for experimental therapies.

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U.S. House passes 21st Century Cures Act

Wednesday, July 15, 2015

The U.S. House of Representatives has approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 and now goes to the U.S. Senate for consideration. This legislation would reauthorize the National Institutes of Health, focus efforts to increase strategic investments and medical research at the NIH and modernize the approval and regulatory process for new drugs, biologics and medical devices at the FDA.  On May 21, 2015, the bill passed the House Energy and Commerce Committee by a vote of 51–0. 

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FDA sued by advocacy groups seeking hepatitis C trials data

Monday, July 6, 2015

Seeking to force faster disclosure of clinical trial data that helped Gilead Sciences win approval for two blockbuster hepatitis C drugs, two public health advocacy organizations filed a lawsuit against the FDA last month—the latest legal action where researchers and patient advocates have scuffled with drug makers and regulators over access to such information.

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