On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more
On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase out petroleum-based synthetic dyes from the US food supply by the end of 2026,...more
7/25/2025
/ Consumer Protection Laws ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Supply ,
Health and Safety ,
Manufacturers ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Requirements
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new dietary ingredient...more
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
On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more
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
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
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 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
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 December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more
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
YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING -
Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
4/19/2024
/ Acquisitions ,
Biopharmaceutical ,
Biotechnology ,
C-Suite Executives ,
CEOs ,
Clinical Trials ,
Events ,
Health Care Providers ,
Health Technology ,
Innovation ,
Investment Banks ,
Investment Funds ,
Investment Opportunities ,
Investors ,
Med Tech ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Regulatory Requirements ,
Research and Development ,
Supply Chain ,
Venture Capital
Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations.
Investing in pharma services is complicated, but our team...more