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On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The document clarifies how sponsors,...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
10/1/2024
/ Biden Administration ,
Biologics ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Reports ,
Laboratory Developed Tests ,
Life Sciences ,
Med Tech ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
OCR ,
Pediatrics ,
Pending Legislation ,
Personal Data ,
Pharmaceutical Industry ,
Scientific Research ,
UK
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
7/2/2024
/ Biologics ,
Clinical Trials ,
Congressional Committees ,
Diversity ,
Draft Guidance ,
EU ,
European Commission ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Patient Privacy Rights ,
Pediatrics ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Proposed Legislation
In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform...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
4/1/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biden Administration ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Clinical Trials ,
Cybersecurity ,
Drug Pricing ,
EU ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
NIST ,
Pharmaceutical Industry ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Reform ,
Research and Development ,
Sensitive Personal Information ,
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
1/4/2024
/ Advertising ,
Biosimilars ,
Center for Biologics Evaluation and Research (CBER) ,
Clinical Trials ,
Compliance ,
Draft Guidance ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicare ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Standards ,
Research and Development ,
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
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
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.” FDA...more
On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and...more
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
6/30/2023
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Marketing ,
Marketing Authorization Application ,
Med Tech ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more