On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
8/26/2024
/ 510(k) RTA ,
Applications ,
Artificial Intelligence ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Impact Assessments ,
Machine Learning ,
Medical Devices ,
Modification ,
Pre-Market Notification ,
Software
On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more
On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more
6/25/2024
/ Cannabis-Related Businesses (CRBs) ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Law Enforcement ,
Marijuana ,
Motion To Reschedule ,
Notice of Proposed Rulemaking (NOPR) ,
Proposed Rules ,
Research Funding ,
Schedule I Drugs ,
Tax Deductions
The U.S. Food and Drug Administration (FDA or Agency) has issued draft guidance, Use of Data Monitoring Committees in Clinical Trials, that applies to sponsors of clinical trials of investigational drugs, biologics, and...more
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more
After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all medical devices into Class I,...more
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies Designation Program, an initiative intended...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
10/11/2023
/ Artificial Intelligence ,
Cybersecurity ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Machine Learning ,
Medical Devices ,
NTIA ,
Popular ,
Premarket Approval Applications ,
Risk Management ,
Software ,
Source Code
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
10/3/2023
/ CLIA ,
Draft Guidance ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Jurisdiction ,
Laboratory Developed Tests ,
Litigation Strategies ,
Medical Devices ,
Proposed Rules ,
Public Comment ,
Reporting Requirements ,
Warning Letters
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
Would Require In-Person Examination In Many Prescribing Scenarios -
Almost fifteen years ago, Congress amended the Controlled Substances Act (CSA) to reduce illegitimate, Internet-based access to controlled drugs while, at...more
On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more
12/20/2022
/ Citations ,
Draft Guidance ,
FDARA ,
FDASIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Medical Devices ,
OSHA ,
Pharmaceutical Industry ,
Prescription Drugs
The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more
On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more
With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more
During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more
On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...more
On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more
FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more
There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated...more
Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) announced the appointment of Professor Kevin Fu, Associate Professor at the University of Michigan, as the Center’s first Acting Director of Medical...more
Effective March 22, 2021, USDA’s Final Rule Sets Forth Regime for Producing Hemp Products in the United States, Superseding Interim Rule -
On January 9, 2021, the U.S. Department of Agriculture (USDA) issued a final rule...more
2/3/2021
/ Biden Administration ,
Cannabidiol (CBD) oil ,
Corrective Actions ,
DEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Hemp ,
Hemp Cultivation ,
Notice of Violation ,
USDA
Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for...more
On 19 November 2020, the European Court of Justice (“ECJ”) ruled on the French ban of cannabidiol (“CBD”) extracted from whole hemp plants in a case relating to the marketing and distribution of hemp oil containing CBD (case...more
12/1/2020
/ Bulgaria ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Czech Republic ,
EU ,
European Court of Justice (ECJ) ,
France ,
Hemp ,
Narcotics ,
Slovakia ,
Sweden ,
Treaty on the Functioning of the European Union (TFEU) ,
Vaping