The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and...more
Colorado Passes New Law -
The Colorado General Assembly recently passed new statute C.R.S. 12-42.5-308, which would require pharmaceutical manufacturer marketing employees or agents to present, at the time of marketing a...more