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
The Way on FDA
News and Insight on FDA...
The Way on FDA, published by Thompson Hine LLP, focuses on legal and regulatory developments related to the U.S. Food and Drug Administration (FDA). The blog covers topics such as FDA import requirements, drug manufacturing technologies including distributed and point-of-care manufacturing, regulatory guidance on medical device submissions like 510(k)s, and FDA policies on emerging products such as vaping and cannabidiol (CBD). It also addresses legislative interactions with FDA regulations and enforcement, providing updates on rules, guidance documents, and industry feedback opportunities. The content is relevant for stakeholders navigating FDA compliance, regulatory strategy, and policy changes affecting pharmaceuticals, medical devices, tobacco products, and related sectors.
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FDA Issues Marketing Denial Orders to JUUL Labs
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…
Detainment Without Physical Examination and the Infant Formula Crisis
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…
U.S. Court of Appeals Weighs in on Hemp-derived Delta-8 THC Classification
Key Notes:
- The Ninth Circuit found that delta-8 THC products are federally legal under the plain meaning of the definition of “hemp” set by the 2018 Farm Bill, making it the first circuit to find such products lawful.
- The Ninth
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A New Way of Approaching What’s for Dinner
Households worldwide are consuming less meat. The United Nations Food and Agriculture Organization reports a steady decline in the consumption of beef products over the past 60 years. In the United States, sales of meat products at grocery stores dropped…