The Food and Drug Administration has just indicated that a lab-grown meat product developed by a California start-up is safe for human consumption. “Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock, poultry, and seafood in the production of food, with these products expected to be ready for […]
Today, the FDA proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans. Under the proposal, manufacturers can label their […]
The US Food and Drug Administration (FDA) recently published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device combination products are complex products for generic drug development purposes. The manual provides definitions and examples of complex drugs and drug-device combination products, as […]
Today, the US House of Representatives to decriminalize marijuana. The House bill, called the Marijuana Opportunity Reinvestment and Expungement Act, or MORE Act, would remove marijuana from the list of scheduled substances and impose a federal tax on marijuana products. It would also establish a process to expunge prior cannabis convictions. The House voted 220-204 […]
Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster. The CDC later added its recommendation and said it would include the FDA’s action in its vaccine guidance. See the agency’s announcement here – Coronavirus (COVID-19) Update: […]
Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well concerning information that should be included in labeling to help assure the continued quality, safety and effectiveness of devices that are intended to be serviced over their […]
As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to the evolving nature of the pandemic. In an update to its guidance on EUAs for COVID-19 vaccines, the FDA details the […]
Virginia lawmakers approved a bill this past weekend that would legalize the sale and recreational use of marijuana beginning in 2024. The move makes Virginia the first Southern state to vote to legalize recreational marijuana, joining 15 other states and the District of Columbia. Per the bill that passed, possession of up to an ounce […]
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and performance of their products. In a recent article, acting FDA Commissioner Janet Woodcock is noted as saying “[t]he purpose of […]
FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular […]
