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Draft Guidance ,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Draft Guidance ,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
On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more
PhRMA, the pharmaceutical manufacturer trade association, announced on Fri. August 6 that it has revised its longstanding Code on Interactions with Health Care Professionals. The revisions, which relate to the Code’s...more
On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more
4/8/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Public Health ,
Relief Measures ,
Supply Chain
With the “patient experience” becoming an increasingly important element in directing not only where industry spends its limited drug development resources but how clinical trials are designed, the U.S. Food and Drug...more