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LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements

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

New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers

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

FDA Continues to Take Stance That it Will Not Issue CBD Rules

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

FDA: New Guidance for Non-interventional Studies of Drug Safety and Effectiveness

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

Clinical Research: FDA Issues Draft Guidance on Informed Consent

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Clinical Trials: FDA Issues Finalized Charging Guidance for Investigational Drug Use 

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

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

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

Opioid Treatment Programs: SAMHSA Makes Permanent Regulatory Flexibilities

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

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

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

FDA: New Draft Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

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

FDA’s New Enforcement Policy: A Win for Remote Patient Monitoring and Remote Therapeutic Monitoring Manufacturers

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

FDA Issues New Warning Regarding Compounded Ketamine

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

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

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

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

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

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

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

Decentralized Clinical Trials: Sponsor Responsibilities

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

Decentralized Clinical Trials: Investigator Responsibilities

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

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

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

Regulation of Digital Health Products by FDA

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 Blog Series: Introduction

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

Reproductive Health: Over the Counter Birth Control Pill Supported by FDA Advisory Committees

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

FDA and SAMHSA Issue Joint Statement in Support of Reducing Barriers to Evidence Based Treatments

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

Gender Affirming Care Restricted Under Missouri Bill

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

Software as a Medical Device: Challenges Facing the Industry

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

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications

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

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