Medical Device Legal News with Sam Bernstein: Episode 11
CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more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
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
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
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 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
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
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
Last month the Massachusetts Department of Family and Medical Leave (DFML) released draft regulations intended to implement the Paid Family and Medical Leave Law (PFML). The PFML is a part of the “Grand Bargain Legislation”...more