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The FDA is planning two surveys of 900 adults each to assess the effect of including more complicated information about prescription drugs in direct-to-consumer television advertisements. 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
CBER has issued nearly identical untitled letters to six manufacturers of allergenic extracts because multiple names were used to reference source materials, which could lead to treatment errors. Read More
Serious adverse events associated with compounded drugs whose labeling doesn’t include any adverse experiences should be considered unexpected and reported to the FDA within 15 days, the agency clarifies in final guidance released Wednesday. Read More