On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more
Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more
7/23/2024
/ Chevron Deference ,
Decision-Making Process ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
7/15/2024
/ Draft Guidance ,
Enforcement ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Internet ,
Medical Devices ,
Pharmaceutical Industry ,
PHSA ,
Policy Statement ,
Prescription Drugs ,
Regulatory Reform
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
Increased public health interest in “forever chemicals” is leading to a new, complex regulatory landscape for manufacturers, distributors, and retailers of foods, cosmetics, and other consumer products. As FDA and other...more
The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more
5/13/2024
/ Competition ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Section 5
On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA’s existing regulatory framework for medical devices under the Federal Food, Drug,...more
On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more
On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more
Executive Summary -
On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more
11/10/2023
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Vaccinations
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
10/25/2023
/ Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Labeling ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Policies and Procedures ,
Regulatory Requirements ,
Regulatory Standards
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance.
FDA justified its reversal on including the...more
In light of the August 30, 2023 historic recommendation from the U.S. Department of Health and Human Services (HHS) to reschedule cannabis to Schedule III, a multidisciplinary group of attorneys from Foley Hoag’s nationwide...more
9/1/2023
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Controlled Substances ,
Controlled Substances Act ,
Criminal Penalties ,
DEA ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Marijuana ,
Medical Marijuana ,
Schedule I Drugs
On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie...more
On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more
7/11/2023
/ Advertising ,
Direct to Consumer Sales ,
Final Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Labeling ,
Marketing ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs
The Food and Drug Administration (FDA) held a stakeholder call on May 25, 2023 to provide additional information related to the agency’s January 26 announcement that it believes a new regulatory framework for cannabidiol...more
6/2/2023
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Decriminalization of Marijuana ,
Food and Drug Administration (FDA) ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Medical Foods ,
Plant Based Products ,
Regulatory Agenda ,
Retail Market
I. WHY THIS CASE MADE THE LIST -
A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
5/24/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CEOs ,
CLIA ,
COOs ,
Corporate Crimes ,
Corporate Executives ,
Corporate Governance ,
Corporate Misconduct ,
Corporate Officers ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
FBI ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Patients ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Wire Fraud
Four months after completing its first premarket consultation, the Food and Drug Administration (FDA) cleared its second premarket consultation for cell-cultivated meat production. We wrote about the first premarket...more
Key Takeaways: Two competing federal court preliminary injunction orders were issued April 7, 2023, which have put the continued availability of mifepristone, the primary drug used for the medical termination of pregnancy, in...more
On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more
On the heels of a January 2023 statement released by the FDA expressing the need for a new regulatory pathway for cannabidiol products, two CBD-related bills were reintroduced in the House of Representatives on March 17,...more
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents.
The Transition...more
Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge’s questions, as reported...more