The Advanced Medical Technology Association (AdvaMed) announced its updated Code of Ethics on Interactions with US Health Care Professionals on October 6, 2025. The medical technology industry has relied on the AdvaMed code...more
11/3/2025
/ Anti-Kickback Statute ,
Compliance ,
Cybersecurity ,
Data Management ,
Data Privacy ,
Data Protection ,
Digital Health ,
Ethics ,
Health Care Providers ,
Medical Devices ,
Popular ,
Regulatory Requirements ,
Transparency
GLP-1 therapies are transforming obesity and chronic disease treatment, yet navigating their complex regulatory landscape remains critical. From the Food and Drug Administration’s ‘Green List’ to state-specific rules,...more
10/15/2025
/ Advertising ,
Compliance Management Systems ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Imports ,
Off-Label Use ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Regulatory Requirements ,
State and Local Government ,
Telehealth
The US Food and Drug Administration (FDA) recently issued warning letters to more than 40 compounding pharmacies, demanding that they cease certain advertising practices for a variety of compounded drug products, including...more
In a marked departure from long-standing practice, the US Food and Drug Administration (FDA) has begun publishing stand-alone complete response letters (CRLs), formal communications that detail the deficiencies in a drug...more
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
The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...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
In April, McDermott gathered more than 100 health and life sciences innovators, investors, business leaders and advisers in Paris for our annual European Health & Life Sciences symposium. With such an esteemed crowd available...more
5/27/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Inflation Reduction Act (IRA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trade Policy ,
Trump Administration ,
US Trade Policies
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 March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more
The Trump administration’s approach to cannabis reform will significantly impact the industry. As the proposed rulemaking to reschedule cannabis unfolds and nominees to critical agencies are confirmed, it is crucial for...more
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
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...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
On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA...more
12/26/2024
/ Comment Period ,
Cosmetics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Listing Rules ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Identifiers ,
Product Labels ,
Product Packaging ,
Registration Requirement
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....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
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list. In particular, FDA updated the availability of...more