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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
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 has granted rare pediatric disease designation to another investigational drug to treat Duchenne muscular dystrophy, this time to Marathon Pharmaceuticals’ deflazacort. Read More