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
Editor’s Note: In recent regulatory and enforcement developments, the White House announced a new executive order aimed at strengthening cybersecurity at U.S. ports, and another executive order was issued to protect sensitive...more
3/7/2024
/ Artificial Intelligence ,
Biden Administration ,
Consent Order ,
Consumer Financial Products ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Fair Credit Reporting Act (FCRA) ,
FCC ,
Financial Services Industry ,
Personal Data ,
Personally Identifiable Information ,
Robocalling ,
TCPA ,
UDAAP
NIST Publishes Report on the Cybersecurity of Genomic Data. On December 20, 2023, the NIST National Cybersecurity Center of Excellence (NCCoE) published Final NIST IR 8432, Cybersecurity of Genomic Data. Informed by direction...more
2/13/2024
/ Artificial Intelligence ,
Biometric Information ,
Biometric Information Privacy Act ,
Consumer Financial Products ,
Consumer Fraud ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Brokers ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Trade Commission (FTC) ,
Financial Services Industry ,
NIST ,
Personal Information ,
Personally Identifiable Information ,
Popular ,
Putative Class Actions