On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
6/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Judicial Authority ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Shortages
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
2/24/2025
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Data Management ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labeling ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Technology
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
10/10/2024
/ Drug Compounding ,
Food and Drug Administration (FDA) ,
Goods or Services ,
Healthcare ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Supply Shortages
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
6/20/2024
/ Artificial Intelligence ,
Biologics ,
Cannabis Products ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more