Informational guidance meetings with representatives from the US Food and Drug Administration (FDA) have been part of the original Prescription Drug User Fee Act ( PDUFA ) and were included in the PDUFA reauthorization in 2012. 1 A second revision of the FDA guidance document for these meetings was released as a draft for comments in March 2015. This new draft guidance updates the meeting instructions and incorporates changes resulting from the Food and Drug Adminis...

The approval and regulation of biosimilar medicinal products (biosimilars) are areas of notable regulatory innovation right now and for the foreseeable future. In the US, the Food and Drug Administration (FDA) has not yet approved a product using the biosimilar pathway, but the agency reports having received nine biosimilar Investigational New Drug applications (INDs) and 35 pre-IND meeting requests for 11 biologic reference products. 1 The European Medicines Agency (EMA...