On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
6/6/2025
/ Consumer Protection Laws ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
State Attorneys General ,
Unfair or Deceptive Trade Practices
The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more
3/26/2025
/ Comment Period ,
DEA ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
New Legislation ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Requirements ,
Telemedicine ,
Trump Administration
In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited...more
1/22/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Health Care Providers ,
Healthcare ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Requirements ,
Ryan Haight Act ,
Telemedicine
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
1/8/2025
/ Compliance ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions.
This hot topic was...more
9/26/2024
/ Analytics ,
Artificial Intelligence ,
Best Practices ,
Compliance ,
Contract Terms ,
Due Diligence ,
Governance Standards ,
Health Care Providers ,
Healthcare ,
Information Security ,
Insurance Industry ,
Machine Learning ,
Medical Devices ,
Policies and Procedures ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Oversight ,
Reimbursements
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more
4/7/2020
/ 510(k) RTA ,
Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Personal Protective Equipment ,
Prescription Drugs