Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more
1/23/2025
/ Department of Health and Human Services (HHS) ,
Drug Safety ,
Food and Drug Administration (FDA) ,
GRAS ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Reform ,
Regulatory Requirements ,
Trump Administration ,
User Fees
What Are GLP-1s? Glucagon-like peptide-1 receptor agonists, also known as GLP-1 drugs, are a class of medications that mimic the action of the glucagon-like peptide-1 hormone, which is involved in the regulation of blood...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
11/3/2023
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
OCR ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Telehealth ,
Tracking Systems
In this month’s Privacy & Cybersecurity Update, we examine the newly established data privacy framework between the EU and U.S. and new consumer privacy laws in Oregon and Texas. We also review a court ruling that delayed...more
8/2/2023
/ Biometric Information Privacy Act ,
California ,
California Privacy Rights Act (CPRA) ,
Cyber Incident Reporting ,
Cybersecurity ,
Cybersecurity Framework ,
Data Privacy ,
Data Transfers ,
Disclosure ,
EU ,
European Commission ,
European Economic Area (EEA) ,
General Data Protection Regulation (GDPR) ,
NYDFS ,
Oregon ,
Popular ,
Privacy Laws ,
Proposed Amendments ,
Regulatory Requirements ,
Risk Management ,
Texas