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On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more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
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
The U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) released a notice of proposed rulemaking to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. HHS seeks...more
On Oct. 7, 2023, Gov. Gavin Newsom signed the California Food Safety Act (CFSA) into law, making California the first state to ban the manufacture, sale, distribution or delivery of food products containing four food...more
In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more
On Aug. 7, 2023, the U.S. Food and Drug Administration (FDA) released draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” which would require facilities that...more
Bidding for attractive businesses in the pharma services space continues to accelerate, with new interest emerging daily from investors who traditionally have not focused on the sector. With this influx comes an urgent need...more
Since mid-2022, the macro acquisition environment has faced the challenges of inflation and increasing interest rates, among a variety of other headwinds. Global deal flow is down from its 2021 peak. Yet, as this white paper...more
Over the past few years, the conversation surrounding recreational and medical use of psilocybin has shifted due to growing evidence of its significant mental health benefits. This newfound social acceptance of psilocybin has...more
Newsworthy Highlights -
California Shuts Down Illegal Cannabis Operation in Monterey County. Recently, officers with the California Department of Fish and Wildlife (CDFW) shut down an illegal cannabis and hemp operation...more
A recent federal court ruling that attempted to set down a distinct line between marijuana and low-THC products (like CBD and delta-8) has led many to make broad conclusions as to what it means for various products. Courts...more
Newsworthy Highlights -
Company to Expand Clinical Trial of Cannabis Therapy for Tourette Syndrome. A pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system...more
On July 13, 2022, Washington, D.C., Mayor Muriel Bowser signed new employment protections into law. Although currently unfunded, the Cannabis Employment Protections Amendment Act of 2022 will prohibit employers from taking...more
Newsworthy Highlights -
D.C. Passes Emergency Bill Allowing Adults to Self-Prescribe Medical Marijuana. Recently, D.C. councilmembers unanimously voted to pass, and D.C. Mayor Muriel Bowser signed, an emergency bill...more
On June 24, 2022, in a 6-3 decision, the U.S. Supreme Court upheld the state of Mississippi’s ban on abortions after 15 weeks of pregnancy. Five justices joined Justice Samuel Alito’s opinion for the Court, with Chief Justice...more