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Sponsors of the CBD Product Safety and Standardization Act (H.R. 6134) expressed disappointment with technical assistance the FDA provided in response to their legislation, calling it “a completely insufficient response.” The bill requires FDA to regulate food containing cannabidiol (CBD) derived from hemp as a food additive.

The 2018 Farm Bill explicitly left FDA the

A federal court ordered Morton Grove Pharmaceuticals on Friday to stop “directly or indirectly manufacturing, processing, packing, labeling, holding, or distributing any drug” product citing GMP regulations. The company is restrained from the aforementioned activity until its GMP operations are in compliance with applicable laws and regulations and certified as such by an expert.


The FDA on Tuesday issued a rule approving the sale of over-the-counter hearing aids. The move could save consumers thousands of dollars and also opens the door for increased competition. In anticipation of Agency approval, companies such as Bose have been developing new products that will not only be less expensive but perhaps also more

The Court of Appeals for the Second Circuit ruled Monday that Pfizer’s program to make its drug tafamidis more affordable violated the federal Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7(b)(2)(B).

The drug is currently the only drug approved by the United States to treat transthyretin amyloid cardiomyopathy, a rare and progressive heart condition, and costs

The FDA will seek external review of its Food Safety and Tobacco offices, Commissioner Robert Califf announced Tuesday. The announcement is most likely a reaction to scrutiny over the handling of certain tobacco and food matters – specifically its regulation of e-cigarettes and infant formula.

Califf did not cite specific concerns, but stated that “the

On July 6, FDA announced the availability of a final guidance for industry entitled “Hazard Analysis and Risk-Based Preventative Controls for Food for Animals.” The guidance is intended to help animal food facilities comply with the hazard analysis and risk-based preventative controls under Current Good Manufacturing Practices (CGMPs).

Animal food facilities currently must comply with

FDA’s user fee programs for prescription and generic drugs, medical devices, and biosimilars must be reauthorized by September 30, 2022. On June 8, 2022, the House passed its version of the Food and Drug Amendments of 2022, and on June 14, 2022, the Senate HELP Committee marked up the similarly situated Food and Drug Administration

FDA today issued MDOs to JUUL Labs for all products currently marketed in the Untied States. In citing the rational for the Orders, FDA stated that the “applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health

FDA’s efforts to ensure that infant formula – often the sole source of nutrition for infants – is safe have typically exceeded the Agency’s approach to traditional food products. For instance, the Food and Drug Administration (“FDA” or “Agency”) has a policy of annually inspecting formula manufacturers, while traditional food facilities are inspected once every