Enforcement Relief: What New Regulatory Reforms Could Mean for Hospices
Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...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 February 15, a bipartisan group of five Congressional Representatives introduced the Pet Food Uniform Regulatory Reform Act of 2024 (the PURR Act) in the U.S. House. Currently, the FDA’s regulation of pet foods is...more
On December 7, U.S. Representative Greg Pence (R-IN) introduced the Innovative Feed Enhancement and Economic Development Act of 2023 (the Innovative FEED Act). Sen. Roger Marshall (R-KS) introduced the Senate version of the...more
The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more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
The U.S. Food and Drug Administration (FDA) released a public inventory on July 12, 2023, of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally...more
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023 (H.R. 2617), which by its name does not appear to have anything to do with cosmetics. However, buried in the approximately 1,650...more
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers. Key Points: ..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more
On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. ...more
USDA Withdraws Organic Livestock and Poultry Rule - The U.S. Department of Agriculture (USDA) has issued a final rule withdrawing the Organic Livestock and Poultry Practices Rule, leaving existing organic regulations in...more
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more