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.
Eight drugmakers have contributed more than $10 million in recent weeks, with Johnson & Johnson putting in more than half the total, to fight a proposed November 2016 ballot initiative in California that would cut state spending on prescription drugs. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
President Barack Obama late Wednesday signed into law a bill to compensate patients who participate in clinical trials involving rare diseases. Read More
Long-term efficacy data on two multiple sclerosis drugs — Novartis’ Gilenya and Sanofi’s Lemtrada — back their ability to keep relapsing MS at bay, while Roche’s investigational ocrelizumab performed well in both relapsing and primary progressive forms of the disease. 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
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