FDA

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published a rule in the Federal Register that proposed amending its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food,…

On March 10, 2023, the Food and Drug Administration (FDA) published a proposed rule titled “Requirements for Tobacco Product Manufacturing Practice.” For more, read the public comment letter and fact sheet, which highlights…

The Food and Drug Administration (FDA) has extended the public comment period for two proposed tobacco product standards by 30 days. The proposed rules would prohibit menthol as a characterizing flavor in cigarettes and prohibit…

On May 4, 2022, the Food and Drug Administration (FDA) published proposed rules that would ban menthol cigarettes and flavored cigars. The proposed “Tobacco Product Standard for Menthol in Cigarettes” would prohibit menthol as a…

On February 23, 2022, the Food and Drug Administration (FDA) published a long-awaited proposed rule titled, Quality System Regulation Amendments (87 Fed. Reg. 10119). The proposed rule covers medical devices and seeks to amend the…

The Food and Drug Administration’s (FDA) final Deeming Rule requires manufacturers of deemed tobacco products to submit their products to the agency for approval before those products can be introduced into the market. On September 25,…

The Food and Drug Administration’s (FDA) final Deeming Rule requires manufacturers of deemed tobacco products to submit their products to the agency for approval before those products can be introduced into the market. On September 25,…

On September 21, 2020, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “Food…

By Charles Jeane, Assistant Chief Counsel On August 19, 2020, the United States District Court for the District of Columbia issued a Memorandum Opinion and Order enjoining the Food and Drug Administration (FDA) from enforcing its…

On July 22, 2020, The Food and Drug Administration (FDA) issued a guidance that outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and…