On December 10, 2024, Senator Markey (D-Mass) and Senator Mike Braun (R-Ind.) sent a letter to various private equity (PE) firms who have invested in opioid treatment programs (OTPs). The letter requested information...more
What Are ADCs and Why Are They Growing?
Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the...more
Brand companies who own GLP-1 products have been pushing the Food and Drug Administration (FDA) to limit their compounding. On August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product,...more
On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more
11/21/2024
/ Abbreviated New Drug Application (ANDA) ,
Cloud Computing ,
Corrective Actions ,
Data Collection ,
Data Management ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Information Technology ,
Policies and Procedures ,
Record Retention
Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while...more
The Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET), effective August 12, 2024, to provide “transparent, predictable, and expedited national...more
This is the fifth edition of our blog series on decentralized clinical trials DCTs. Click here to explore the series.
The COVID-19 Pandemic required the health care industry to adapt to accommodate remote patient care,...more
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