The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more
FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to...more
On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A...more
6/23/2021
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Federal Meat Inspection Act (FMIA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Genetically Engineered Animals ,
Memorandum of Understanding ,
Poultry Products Inspection Act (PPIA). ,
Proposed Rules ,
Regulatory Oversight ,
USDA
US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other...more
6/2/2021
/ Beverage Manufacturers ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Health and Safety ,
Legislative Agendas ,
Marijuana ,
Plant Based Products ,
Regulatory Agenda ,
Regulatory Oversight
A US Court of Appeals for the Ninth Circuit panel recently affirmed a decision by the US Food and Drug Administration (FDA) approving soy leghemoglobin (also known as “heme”), a soy protein ...more
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more