Medical Device Legal News with Sam Bernstein: Episode 11
Regulation of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) in soils under New York’s remedial programs was a little erratic in 2024. As to their inclusion in the New York State Department of...more
In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of...more
On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial...more
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
Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...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
Employers should take note – the U.S. Equal Employment Opportunity Commission ("the EEOC") unveiled draft regulations and guidance on the new federal Pregnant Workers Fairness Act (PWFA) – and there are numerous noteworthy...more
Summary - The Federal Trade Commission (FTC) and Department of Justice (DOJ) have taken steps to update the Merger Guidelines and overhaul the premerger notification process, each with a sharpened focus on the effect a...more
FDA recently issued two nutrition-related initiatives regarding dietary guidance statements and the use of salt substitutes in standardized foods. The first initiative, a draft guidance, contains agency recommendations on the...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
This briefing is the second in a series of briefings by Walkers’ on the Lending, Credit and Finance (Bailiwick of Guernsey) Law, 2022 (the “LCFL”), and provides an overview of the licensing regime applicable to consumer...more
FINRA recently published a “Discussion Paper” on expungement of customer dispute information in which it outlines its plans going forward on revising the expungement process. Expungement_Discussion_Paper.pdf (finra.org) (Let...more
As part of its review of the EU antitrust rules governing vertical agreements, the European Commission (EC) has published for consultation a draft new section of its Vertical Guidelines, which contains proposed guidance on...more
This week in Washington: Congressional Democrats reach drug pricing agreement; bipartisan infrastructure bill goes to President Biden’s desk with budget reconciliation bill delayed....more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take...more
On June 28, 2016, the US Securities and Exchange Commission (SEC) proposed new Rule 206(4)-4 (Proposed Rule) under the Investment Advisers Act of 1940, as amended (Advisers Act) and also proposed amendments to certain...more