Medical Device Legal News with Sam Bernstein: Episode 11
If accepted, the new Draft Regulatory Guide DG-4034, “General Site Suitability Criteria for Nuclear Power Stations,” may facilitate the siting of both advanced and traditional reactors closer to population centers. The...more
The Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) jointly issued new draft Merger Guidelines on July 19. The draft Merger Guidelines were created with the goal "to better reflect how the agencies...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
It has been a bustling fall for the California Privacy Protection Agency (CPPA or Agency). In the spirit of the upcoming holiday season, the Agency gifted us not one but two rounds of proposed modifications to the regulations...more
On February 14, 2020, the State Water Resources Control Board (SWRCB) and the California Department of Toxic Substances Control (DTSC) issued a public notice regarding the release of Draft Supplemental Guidance: Screening and...more
The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more
The Federal Trade Commission (FTC) and Department of Justice (DOJ) have extended the deadline for public comments on the draft vertical merger guidelines (the Guidelines), which were published jointly by the agencies on 10...more
The U.S. Department of Justice and the Federal Trade Commission (collectively, “Agencies”) recently released for public comment their much-anticipated draft Vertical Merger Guidelines (“Guidelines”) that purport to “outline...more
Last week, the U.S. Department of Justice ("DOJ") and Federal Trade Commission ("FTC") issued draft Vertical Merger Guidelines. Vertical mergers combine two or more companies operating at different levels of a supply chain...more
On January 10, 2020, the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) released for public comment draft Vertical Merger Guidelines. Vertical mergers are those that combine companies...more
On Friday, the Federal Trade Commission (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) released joint draft Vertical Merger Guidelines (“Guidelines”) for public comment. This much anticipated...more
On January 10, 2020 the United States Department of Justice (DOJ) and the Federal Trade Commission (FTC) released draft guidelines outlining the agencies' "analytical techniques, practices, and enforcement policy" for...more
On Friday, 10 January 2020 the Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the agencies) announced the publication of draft vertical merger guidelines that describe how the agencies currently...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
The Ohio Department of Health (ODH) has prepared draft amendments to Ohio’s Certificate of Need (CON) rules. A number of these draft rule amendments address changes to the CON laws that were made in Ohio’s general operating...more
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking public comment on draft instructions to validate a refining process under the National Bioengineered Food Disclosure Standard...more
On October 9, 2019, President Trump signed two executive orders: Promoting the Rule of Law Through Improved Agency Guidance (Executive Order 13891) (the “Guidance Executive Order”) and Promoting the Rule of Law Through...more
Bloomberg Law reported this week that California Attorney General Xavier Becerra expects to issue draft regulations for the California Consumer Privacy Act (CCPA) in October....more
The Securities and Exchange Commission announced an open meeting for August 21st in order to consider: guidance regarding the proxy voting responsibilities of investment advisers under Rule 206(4)-6 under the Investment...more
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more
FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more
The primary objective of the guidelines is to improve financial reporting by addressing issues related to P3s and APAs. The guidelines provide uniform guidance on accounting and financial reporting for transactions that meet...more
Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more
On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft manual guidance for surveyors evaluating whether hospitals that are co-located with other hospitals (or with other health care entities) meet the...more
Last week, the FDA released a draft guidance regarding the low calorie sweetener, allulose, and stated the agency will not treat this ingredient as contributing to total or added sugars content in the nutrition information....more