LEGISLATION, REGULATIONS & STANDARDS - FDA Provides Update on Antimicrobial Resistance - The U.S. Food and Drug Administration (FDA) has published Commissioner Scott Gottlieb’s September 14, 2018, remarks delivered at...more
Advocacy Groups Urge Senate to Support NOSB - A group of advocacy organizations has sent a letter asking the leaders of the Senate Committee on Agriculture, Nutrition & Forestry to “fully support organic agriculture in the...more
OIG Report Suggests Improvements to FSMA Enforcement - A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug Administration (FDA)...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more