The European Medicine Agency’s revised guideline on the chemistry of active substances — outlining the information companies must provide the agency about the chemical entities used in a drug product…

The FDA sent an untitled letter to the Avella Specialty Pharmacy in Phoenix, Ariz., for labeling and reporting violations. Source: Drug Industry Daily

More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms…

The European Medicines Agency plans to launch an improved version of its adverse event monitoring system, EudraVigilance, in November, with new methods for reporting and analyzing suspected reactions to investigational…