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 FDA has tentatively declared that vinpocetine does not classify as dietary ingredient, citing its clinical investigation as a new drug and composition as a synthetic compound. Read More
The FDA has extended the review period for Novo Nordisk’s Type 2 diabetes candidate IDegLira, just weeks after the agency delayed its decision on a comparable therapy by Sanofi. Read More
Presidential hopeful Hillary Clinton has unveiled a plan to rein in exorbitant drug costs for lifesaving treatments that would penalize drugmakers for price-gouging. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
Nearly two years after the agency said that it would review its regulatory framework on off-label use, the FDA announced that it would hold a meeting Nov. 9 and 10 to involve stakeholders in the framing of guidance and regulations on unapproved uses. Read More
Drug safety label information will be available closer to its approval date now that CDER’s Office of Communications is handling label changes, CDER Director Janet Woodcock announced Thursday. Read More