Podcast - Made in the USA Claims
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In early July the Staff of the Federal Trade Commission (FTC) issued new guidance on how to approach Made in USA claims. The agency says the new guidance will help businesses comply with its “all or virtually all” standard,...more
On July 2, 2024, the Federal Trade Commission announced a “refreshed version” of the agency’s Complying with the Made in USA Standard guidance document. The refreshed guidance document includes, without limitation, updated...more
Infant formula manufacturers should be aware of several recent actions taken by the Food and Drug Administration (FDA). In total, these actions reflect FDA's dedication of resources to the infant formula industry....more
The Federal Trade Commission (FTC) has increasingly prosecuted more deceptive U.S. origin claims under Section 5 of the FTC Act since the start of the COVID-19 pandemic than in the previous decade. This uptick in...more
Our recent briefing note explained that CE product safety marking, which is required to sell certain types of goods in the European Union, was being replaced by the UKCA mark in Great Britain (GB) following Brexit. The...more
The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to...more
Join key industry stakeholders to discuss the latest developments affecting the dietary supplement industry. Now in a Virtual Format. American Conference Institute (ACI) together with the Council for Responsible Nutrition...more
Dietary supplement manufacturers seeking to explain and market their products must carefully craft statements on supplement labels to ensure compliance with the Food and Drug Administration's ("FDA's") regulations regarding...more
On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product...more
FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more
One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more