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Customs and Trade Law Weekly Snapshot

Customs & International Trade Law

Here is a recap of the latest customs and international trade law news: FDA. Food and Drug Administration ( FDA ) announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry. On April 28, 2022, The U.S.

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Customs and Trade Law Weekly Snapshot

Customs & International Trade Law

Here is a recap of the latest customs and international trade law news: AD/CVD. On April 15, 2022, the FDA published a draft guidance for industry on developing drugs to treat celiac disease, “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” million, Italy at $72.54 million, and France at $67.39

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). We do not address the technical and administrative details of the Discount Program here.