Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Methylene chloride, also known as dirchloromethane [osha.gov], is a volatile, colorless liquid with a chloroform like odor. Historically, it has been used in various industrial processes, such as pharmaceutical manufacturing,...more
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more
On May 10, the U.S. Food and Drug Administration (“FDA”) released a new guidance document Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution,...more
For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...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
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more
A bipartisan coalition of AGs from 27 states, the District of Columbia, and three territories has called on the FDA to deny marketing authorization for non-tobacco nicotine products (NTNs) which are currently marketed without...more
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
The US Food and Drug Administration (FDA) published its Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (final guidance) on March 4, 2022. The final guidance describes how...more
On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and...more
Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”), a sweeping package broadly...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more