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Medical Devices

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?

The de novo process employed by FDA’s Center for Devices and Radiological Health (CDRH) is a less frequently used mechanism for the clearance of medical …

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Agriculture & Agribusiness

FDA’s Woodcock Holds Meeting on Regulatory Pathways for Hemp and CBD

On November 1, 2022, the Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA) Janet Woodcock had a virtual meeting on “Regulatory Pathways …

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OFW Law News

Mark Mansour Joins OFW

We are delighted to announce that Mark Mansour has joined OFW as Of Counsel, working principally with our FDA Food and Medical Device Practice groups. …

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Food Distribution & International Trade

SEC Stock Promotion Scheme Charges Against the Cannabis Industry

In October, the United States Securities and Exchange Commission (SEC) announced that it would be charging two (2) cannabis companies, Emerald Health and HighTimes, and six …

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FDA

FDA Warning Letters to Walmart and Amazon for Selling Drug Products Deemed Illegal

On October 28, 2022, the United States Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) issued warning letters to both Walmart …

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FDA

October Food and Agriculture Regulatory Recap

OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments …

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Updates from Olsson Frank's Twitter:

Modernizing Food SOI has been on FDA's radar for the last 20 years, but there has been very little movement on the subject until this past year. On Wednesday, FDA announced that it is revoking the SOI for French Dressing.
https://ofwlaw.com/modernization-of-principles-for-food-standards-of-identity-soi-in-a-long-line-of-what-needs-to-be-done-french-dressing-soi-revoked/

SCOTUS convened a special hearing on Friday to hear oral arguments regarding the vaccine-or-test mandates.
https://ofwlaw.com/vaccine-or-test-mandates-us-supreme-court-oral-arguments-on-friday/

On December 18, 2021, regulations implementing the TMA went into effect. By amending the Lanham Act, individuals, businesses, and the USPTO now have new tools at their disposal.

https://ofwlaw.com/trademark-modernization-act-took-effect-december-18-2021/

The 6th Circuit is chosen from the lottery to hear the the consolidated lawsuits against OSHA ETS!
https://ofwlaw.com/6th-circuit-selected-in-lottery-to-hear-lawsuits-against-osha-ets-vaccine-and-testing-mandate/

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