On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill No. 5159, “An Act enhancing the health care market review process” (“H. 5159”), which was passed by the Massachusetts legislature in the last...more
1/10/2025
/ Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Private Equity ,
Regulatory Requirements ,
REIT ,
Reporting Requirements ,
State and Local Government
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
9/6/2023
/ Clinical Trials ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Scientific Research
While the COVID-19 pandemic seems to be moving into our rearview mirror, government investigations and enforcement actions targeting COVID-19-related fraud are just starting to heat up.
What can businesses do to prevent or...more
What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to...more