FDA Law Blog
DECEMBER 3, 2023
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.
Customs & International Trade Law
APRIL 29, 2022
Food and Drug Administration ( FDA ) announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry. CBP officers determined that the rings had a total Manufacturers Suggested Retail Price (MSRP) value of approximately $15,000.
Customs & International Trade Law
APRIL 22, 2022
On April 15, 2022, the FDA published a draft guidance for industry on developing drugs to treat celiac disease, “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” The top three deficits through February of this year were with Nicaragua at $84.41 million, Italy at $72.54 million, and France at $67.39
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