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/ Draft Guidance ,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On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more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
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
Following the landmark October 30, 2023 executive order on artificial intelligence (AI), the White House Office of Management and Budget (OMB) issued a draft memorandum to federal agency heads for the use of AI within their...more
On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more
10/31/2023
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Pharmaceutical Industry ,
Prescription Drugs ,
Technology Sector ,
Telemedicine
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
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
As of June 21, 2023, two food companies have received a grant of inspection from the U.S. Department of Agriculture (USDA) for their cell-cultivated chicken. This means the two companies, GOOD Meat (a division of Eat Just,...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
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
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) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more
The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more
1/19/2023
/ Cosmetics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
New Regulations ,
Personal Care Products ,
Product Labels ,
Product Safety Labels ,
Proposed Legislation ,
Registration Requirement ,
Regulatory Oversight ,
Reporting Requirements
Key Takeaways:
The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials.
FDA’s recommendations come as part of increasing interest in ensuring clinical...more
4/20/2022
/ Abbreviated New Drug Application (ANDA) ,
Biden Administration ,
Biologics ,
Black and Minority Ethnic (BME) ,
Clinical Trials ,
Corporate Counsel ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
FDASIA ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Licenses ,
National Institute of Health (NIH) ,
Premarket Approval Applications ,
Sponsors
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more
Key Takeaways:
▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more
2/14/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Standards ,
Supply Chain ,
Third-Party
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more
10/29/2021
/ Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Canada ,
Healthcare ,
International Medical Device Regulators Forum (IMDRF) ,
Machine Learning ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
Regulatory Oversight ,
Technology Sector