In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more
5/5/2025
/ Artificial Intelligence ,
Biologics ,
Biotechnology ,
Clinical Trials ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Investment ,
Investors ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Technology Sector ,
Venture Capital
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more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 January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies.
Under the new...more
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
Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including:
- The EU’s new Unified Patent Court...more
6/17/2024
/ Artificial Intelligence ,
EU ,
Financial Regulatory Reform ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector ,
Unified Patent Court
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