On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more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
The U.S. Food and Drug Administration (FDA) has demonstrated a commitment to expanding diversity in clinical trials. Decentralized Clinical Trials ( DCTs) contribute to this effort by enhancing convenience for trial...more
On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more
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we address U.S. Food and Drug Administrations’ (FDA) expectations of investigators articulated in the recently released draft guidance....more
On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more
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
On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19...more
In an unprecedented move, the U.S. Food and Drug Administration (FDA or Agency) sent a warning letter to Amazon.com, Inc. (Amazon), a fulfillment house, with respect to distributing over-the-counter (OTC) drug products that...more
The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key...more
On August 13, 2021, the State of Illinois enacted a law, amending the Illinois Freedom To Work Act (the Law) to limit the enforceability of non-competition and non-solicitation agreements between employers and employees in...more
Three partners in Foley’s health care industry team—Monica Chmielewski, Jana Kolarik, and Lori Rubin—attended the Federation of American Hospitals (FAH) Conference and Business Exposition from June 6-8, 2021 in Nashville,...more
On October 1, 2020, the Department of Health and Human Services (HHS) announced a new $20 billion Phase 3 of the Provider Relief Fund (PRF) General Distribution. Much like the Phase 2 funding, Phase 3 funding will be made...more
On September 19, 2020, the Department of Health and Human Services (HHS) released guidance establishing the reporting requirements for health care providers that received Provider Relief Fund (PRF) payments. These reporting...more
9/24/2020
/ Audits ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FEMA ,
Medical Expenses ,
New Guidance ,
Nursing Homes ,
Paycheck Protection Program (PPP) ,
Provider Relief Fund ,
Rural Health Care Providers ,
SBA ,
State and Local Government ,
Tribal Governments
On January 25, 2019, the Illinois Supreme Court handed down a key ruling that will make it significantly easier for consumers and workers to sue and recover damages for mere non-compliance with the requirements of the state’s...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS
The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more
The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more