On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more
5/5/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Manufacturers ,
Medicaid ,
Medicare ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
1/14/2020
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
A complex—and occasionally, inconsistent—patchwork of federal and state regulatory requirements apply to entities that perform human subjects research in the United States. In recognition of one such inconsistency, the...more
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more
Two recently released reports from the U.S. Department of Health and Human Services (HHS) and the U.S. Government Accountability Office, respectively, focus on the impact of prescription drug shortages, their potential causes...more