Legal Alert: USPTO Proposes Major Change to Terminal Disclaimer Practice
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
The FTC’s Rule Banning Non-Compete Agreements | What You Need to Know
An In-Depth Analysis of the CFPB’s Proposed Overdraft Rule - The Consumer Finance Podcast
The FTC Takes Initiative to Stop Junk Fees
Understanding the CFPB's Proposed Digital Payments Larger Participants Rule and Its Implications for Digital Assets — The Consumer Finance Podcast
Instant Decline, Instant Relief? Unpacking the CFPB's Proposed Rule on NSF Fees — Payments Pros: The Payments Law Podcast
Redefining Banking: A Conversation on the CFPB's Proposed 1033 Rule — Payments Pros: The Payments Law Podcast
DE Under 3: FAR Council Submitted for OMB Approval Proposed Rule on “Pay Equity and Transparency in Federal Contracting”
The FTC Announces Three Important Developments
Exploring the Future of Open Banking: A Discussion on CFPB's 1033 Proposed Rule – Crossover Episode With Regulatory Oversight Podcast – The Consumer Finance Podcast
Exploring the Future of Open Banking: A Discussion on CFPB's 1033 Proposed Rule — Regulatory Oversight Podcast
The Future of Digital Consumer Payment Applications: CFPB's Proposed Larger Participant Rule – The Consumer Finance Podcast and Payments Pros Podcast
Alternatives to Noncompetes: Intellectual Property Alternatives to Noncompetes
Employment Law Now VII-135-Summer 2023 Wrap-Up Part 1 (NEW DOL OVERTIME RULE)
Podcast - Insights on the FTC's Approach to Digital Health Companies
Podcast - SEC's Oversight on Cybersecurity Requirements
The FTC's Proposed Rule to Fight Impersonation Scams
CFPB's Larger Participant Rule for Consumer Payments - The Consumer Finance Podcast
Podcast - The Latest on Antitrust and Non-Compete Agreements in Healthcare
On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more
After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a somewhat surprising move, the...more
The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...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
The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating...more
In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more
Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted. The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents - the draft guidance titled “The ‘Deemed to be a...more
On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more