A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain...more
Holland & Knight's Healthcare & Life Sciences Policy Team regularly provides updates through our weekly Health Dose. This special Health Dose: Post-Election Edition is intended to outline the short- and long-term potential...more
11/12/2024
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Intent ,
Election Results ,
Federal Budget ,
General Elections ,
Health Care Providers ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
NDAA ,
Political Parties ,
Presidential Elections ,
Public Policy
As Congress reconvenes, it faces a packed agenda in a legislative year that will be shortened by the upcoming midterm elections and remains buffeted by the persistent coronavirus pandemic. The list of healthcare priorities is...more
1/7/2022
/ Affordable Care Act ,
Appropriations Bill ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Coronavirus/COVID-19 ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Graduate Medical Education ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Industry Consolidation ,
Legislative Agendas ,
Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
NDAA ,
Proposed Legislation ,
Public Health ,
Public Health Emergency ,
Surprise Medical Bills ,
Telehealth ,
Water Resources Development Act
On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
12/12/2017
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Software ,
Patients ,
Public Comment ,
Software Developers ,
Technology Sector