We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
The FDA has fast-tracked the third potential treatment for Duchenne Muscular Dystrophy this year, granting the designation to New Jersey-based Tarix Orphan for its TXA127. Read More
The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More