As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
7/9/2025
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Budget Reconciliation ,
Deregulation ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medical Technology Companies ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
UK
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
4/1/2025
/ Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
US Trade Policies
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
1/17/2025
/ Communication Restrictions ,
Compliance ,
Disclosure Requirements ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
New Guidance ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
10/2/2023
/ Biologics ,
Clinical Trials ,
Compliance ,
Diagnostic Tests ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Public Consultations ,
Regulatory Oversight ,
Regulatory Requirements ,
UK