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.
Reducing the collection of safety data in late-stage and postapproval clinical trials can improve trial efficiency, the FDA says in a final guidance published on Monday. Read More
President Biden has signed into law a bill that creates a new registration process for carrying out marijuana-related research and for facilitating the development and manufacturing of marijuana-based drugs. Read More
The FDA should take a page out of one online retail giant’s book, says Commissioner Robert Califf, as it works to update its technology infrastructure and make its processes and interactions with industry as efficient as possible. Read More
Sponsors hoping to use equivalence criteria in analyzing bioequivalence (BE) studies for their drug applications just got more details on how the FDA wants them to undertake that. Read More
The European Medicines Agency (EMA)’s safety committee has recommended withdrawing medications containing pholcodine, an opioid active ingredient used alone or in combination with other substances, to treat dry cough, cold and flu symptoms. Read More
The most challenging drug shortages the U.S. faces are not the new ones that crop up from illnesses like COVID-19 or the current spike in respiratory illnesses. Rather, the shortages that have been ongoing for years cause the FDA the most strife. Read More
In a deal set to strengthen two different clinical research platforms, Bluebird Bio has sold one of its rare pediatric disease priority review vouchers (PRV) to the immunology company Argenx for $102 million. Read More