Medical Device Legal News with Sam Bernstein: Episode 11
On December 18, 2023, the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) (together, the “agencies”) jointly released their final revised 2023 Merger Guidelines, reflecting modest adjustments...more
On December 18, 2023, the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) released the final 2023 Merger Guidelines (the Guidelines). While the final version of the Guidelines reflects...more
The US Federal Trade Commission (FTC) and US Department of Justice Antitrust Division (DOJ) issued their updated Merger Guidelines on December 18, 2023. These guidelines represent a significantly more...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
The U.S. Food and Drug Administration (FDA) has extended the comment period for its proposed new “healthy” regulations for food packaging. The new deadline for comments is February 16, 2023. The 50-day extension follows...more
On January 7, 2019, the federal Office of Management and Budget (OMB) released a draft of a memorandum setting forth guidance to assist federal agencies in developing regulatory and non-regulatory approaches regarding...more
On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current...more
As part of the Commission’s Digital Single Market initiative, the European Commission has published a draft Regulation aimed at preventing traders from discriminating against customers based on nationality or location. The...more
Colorado’s uninsured rate is down 9 percentage points in four years; Michigan requests increased cost-sharing for its Medicaid expansion population above the federal poverty line; and, HHS’s proposed guidance strengthens...more
On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more
On August 26, 2015, the Section of Public Contract Law of the American Bar Association (“ABA”) submitted public comments to the General Services Administration (“GSA”) and the U.S. Department of Labor (“DOL”) on their...more
On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more
On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more
GOVERNMENT CONTRACTS - DOD Issues Report Entitled Defense Contracts: DOD’s Request for Information from Contractors to Assess Prices - The Department of Defense (DOD) has issued a report entitled Defense Contracts:...more
On August 5, 2015, the U.S. Department of Labor (“DOL”) published an announcement in the Federal Register informing the public that both it and the FAR Council have extended the notice and comment period for the proposed...more
On May 27, 2015, the Defense Department, General Services Administration and National Aeronautics and Space Administration announced the Federal Acquisition Regulatory Council’s proposed rule to implement Executive Order...more
Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more