Drug Amount Reporting: FDA Publicly Identifies over 7,700 Noncompliant Companies
By Fabiola C. Gomez, Ph.D., CMC Regulatory Expert —
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By Fabiola C. Gomez, Ph.D., CMC Regulatory Expert —
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to U.S. cosmetic regulation since the Federal Food, Drug, and Cosmetic Act (FD&C Ac...
In the United States, both patent law and U.S. Food and Drug Administration (FDA) regulations govern the commercial availability of drug products and any potential periods of marke...
The draft bill proposes sweeping reforms to FDA’s food safety oversight, including GRAS process changes, infant and baby food safety provisions, and federal preemption of state law...
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...
The 56th session of the Codex Alimentarius Committee on Food Additives (and on Flavorings, Enzymes, Yeasts, and Processing Aids) (i.e., CCFA56) successfully addressed all the top...
On March 27, 2026, the Food and Drug Administration (“FDA”) held a public meeting entitled “Exploring the Scope of Dietary Supplement Ingredients.” Sponsored by FDA’s Office of Die...
The U.S. Food and Drug Administration announced on May 12, 2026, “two decisive actions focused on food chemical safety.” First, FDA released two final documents for its new proacti...
Yesterday FDA released its fiscal year (FY) 2027 budget request of approximately 7.2 billion, an increase of 3.3% as compared to the FY 2026 enacted budget. FDA’s budget consists o...
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...
The bills to be discussed address issues like “Generally Recognized as Safe” (GRAS) determinations, food chemical safety reassessments, food labeling, infant formula and baby food...
Emily Whitest, Research Fellow If you’ve ever read an ingredient list on the back of a bottle of salad dressing or...
By Charles D. Snow & Kalie E. Richardson —
Last week, FDA touted its achievements in connection with implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) – noting that the agency had “worked tirelessl...
A group of dietary supplement companies, joined by an alternative medicine advocacy group, sued FDA (Law360 subscription required) for allegedly violating First Amendment commercia...
On May 12, 2026, FDA announced that the Agency finalized its new “proactive food chemical safety post-market assessment program” and launched reassessments of butylated hydroxytolu...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...
-- OPINION --State leadership vs. a patchwork of regulations sums up of the controversy over the “FRESH Act” in a single phrase.Due to its controversial provisions on federal food...
New York has passed sweeping food additive legislation that, if signed by the Governor, will fundamentally reshape how food manufacturers and suppliers operate in the state....By:...
Highlighting contaminated seafood as a particular concern, the Destruction of Hazardous Imports Act answers FDA’s request for the authority to destroy food imports that do not pass...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...
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