article thumbnail

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. We do not address the technical and administrative details of the Discount Program here. The manufacturer will have 60 days to appeal the CMP before an administrative law judge (ALJ).

article thumbnail

Customs and Trade Law Weekly Snapshot

Customs & International Trade Law

International Trade Commission has determined to review in part a final initial determination (“ID”) issued by the presiding administrative law judge (“ALJ”), finding no violation of section 337 of the Tariff Act of 1930. On May 13, 2022, notice was given that the U.S. On May 13, 2022, notice was given that the U.S.

Laws 98