The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more
In response to increased cybersecurity threats and significant regulatory enforcement actions, on Dec. 27, 2024, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking seeking to enhance...more
On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more
In response to an outbreak of the H5N1 strain of bird flu among dairy cows in at least 15 states, the U.S. Department of Agriculture (USDA) issued a new federal order (the Order) requiring dairy farms and other entities...more
Over 200 fellow healthcare leaders joined the 17th Annual Healthcare Finance and Growth conference for interactive programming discussing the latest developments in the industry and the challenges the industry faces in 2024...more
California and Missouri are the latest states to target hemp-based products containing intoxicating cannabinoids. On Sept. 23, 2024, California signed into law emergency regulations aimed at protecting children from the...more
The U.S. Cybersecurity & Infrastructure Security Agency has deemed healthcare entities “target rich, cyber poor,” meaning they have copious amounts of consumer and patient data but often do not have the cybersecurity means to...more
Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009...more
5/29/2024
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Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of...more
Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009...more
Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of...more
Interest in the potential for psilocybin to be developed as a mental health treatment has continued to grow in recent months, due in part to recent activity by the U.S. Food and Drug Administration (FDA) and Drug Enforcement...more
On Jan. 1, 2024, California’s Proposition 12 (Prop 12) went into full effect, requiring certain farm owners, operators and distributors of covered farm animals such as egg-laying hens, commercial breeding pigs and veal calves...more
The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 CFR 820....more
The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more
On Jan. 12, 2024, the U.S. Department of Health and Human Services (HHS) officially released unredacted documents detailing the U.S. Food and Drug Administration’s (FDA) reasons for recommending that the Drug Enforcement...more
A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by...more
On Dec. 19, 2023, Michael Miller, acting chief of the Drug Enforcement Administration (DEA) Office of Congressional Affairs, penned a letter to Congress advising that DEA is currently reviewing the Department of Health and...more
On Nov. 22, 2023, the U.S. Food and Drug Administration (FDA) published a new resource for manufacturers of critical foods — defined as any infant formula or medical food — reminding manufacturers of their obligation to...more
On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more
On Dec. 6, 2023, the U.S. Food and Drug Administration (FDA) sent a warning letter to the owners of online hemp, tetrahydrocannabinol (THC) and cannabidiol (CBD) retailer Hemp-xr.com for introducing adulterated foods into...more
On Oct. 25, 2023, in light of a “significant rise in the number and severity of cyber-attacks against hospitals and health systems in the last few years,” the U.S. Department of Homeland Security Cybersecurity and...more
In late August 2023, the Department of Health and Human Services (HHS) recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substances Act (CSA), signaling the...more
On Nov. 2, 2023, the Food and Drug Administration proposed revoking the regulation that authorizes the use of brominated vegetable oil (BVO) in food. BVO is a vegetable oil with added bromine that prevents the separation of...more
On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more