On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more
The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol...more
The U.S. Food and Drug Administration (FDA) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, to contribute evidence of...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
3/15/2024
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Informed Consent ,
Penalties ,
Reimbursements ,
Research and Development ,
Risk Mitigation ,
Shareholders
In February 2024, the U.S. Food and Drug Administration (FDA) published its finalized guidance concerning its investigational drug charging regulations (found at 21 C.F.R. § 312.8). These regulations are applicable to...more
In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more
2/27/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Cost-Sharing ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Medicaid ,
Medicare ,
OIG
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services, announced a final rule updating the regulations regarding Opioid Treatment Programs...more
2/12/2024
/ Certifications ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Licensing Rules ,
Medical Evaluation Reports ,
Opioid ,
Public Health Emergency ,
SAMHSA ,
Substance Abuse ,
Telemedicine
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more
12/7/2023
/ Advertising ,
Amended Regulation ,
Direct to Consumer Sales ,
Enforcement ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more
On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (guidance)....more
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
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
10/11/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Proposed Rules ,
Shareholders
In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more
9/12/2023
/ Advertising ,
Compliance ,
Direct to Consumer Sales ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Marketing ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Factors
The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more
In the second edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administrations’ (FDA) expectations of investigators articulated in the recently released draft guidance....more
On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more
Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more
Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...more
At the May 9-10, 2023, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, U.S. Food and Drug Administration (FDA) advisers voted that the...more
On May 9, 2023, the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint statement regarding both agencies’ commitment to providing evidence-based...more
On May 10, 2023, the Missouri legislature passed a bill restricting access to gender affirming care for individuals under the age of 18. The bill is now headed to Governor Parson’s desk for signature...more
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more
5/16/2023
/ Algorithms ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Licensing Rules ,
Medical Devices ,
Popular ,
Reimbursements ,
Software ,
Technology Sector
On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...more