The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of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
On November 16, 2020, the Department of Health and Human Services, Office of Inspector General (OIG) published a Special Fraud Alert for Speaker Programs. The Special Fraud Alert "highlights some of the inherent fraud and...more
On April 4, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance on “Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The...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The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight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