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The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiotics. Read More
The House Energy & Commerce Committee is once again demanding information on the status of all patients in NIH clinical trials affected by the shutdown of the agency’s drug compounding facility, despite receiving a letter from NIH saying there were no negative impacts on affected patients. Read More
President Obama’s nomination of Robert Califf to lead the FDA is drawing praise from those in industry and academia who see him as an outstanding choice and a strong leader deeply respected by the scientific community. Read More
Drugmakers submitting NDAs and BLAs should prepare a comprehensive analysis of all clinical trial data that describes the therapy’s effectiveness, strengths and weaknesses and highlights missing information, such as pharmacokinetic or pharmacodynamic studies, the FDA says. Read More
The FDA is seeking up to nine drugmakers to participate in a four-month pilot project to examine whether final submission of risk evaluation and mitigation strategies can be made more accessible to the public. Read More