On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more
7/29/2025
/ Antitrust Provisions ,
Biologics ,
Biosimilars ,
Competition ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Warning Letters
Last month, on April 22, the Centers for Medicare & Medicaid Services (CMS) issued its Minimum Staffing Standards for Long-Term Care Facilities final rule, which will apply to any long-term care (LTC) facilities that receive...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
4/12/2024
/ Algorithms ,
Artificial Intelligence ,
Bias ,
CDRH ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Manufacturers ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Requirements ,
Risk Management