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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 — goes into effect this week. Read More
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More
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 and authorized products. Read More