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 European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More
The FDA released a draft guidance for the development of drugs that use nanomaterials, stating the importance of describing and analyzing nanomaterials and their attributes in a product’s finished form. Read More
The FDA outlined how it will use information requests and the newly established discipline review letter — which originates from specialized staff concerning their portion of an ANDA review, such as bioequivalence, quality or labeling. Read More
In the coming year, the FDA’s top priorities will include broadening non-prescription access to drugs and updating compounder regulations, according to Commissioner Scott Gottlieb. Read More
The FDA issued a warning to a Korean drugmaker for significant current good manufacturing practice violations and the lack of an adequate quality control unit. Read More