2025 Manufacturing Statute 
FDA Law Blog
MAY 14, 2025
Schwartz In early April, Cellares became the first company to announce receipt of an Advanced Manufacturing Technology (AMT) designation from FDA. The types of supporting data and information to include with a request depend on the specific method of manufacturing and its proposed context of use. Tobolowsky & Mark I.
Conflict of Laws
MAY 9, 2025
23-1141 took place in March 2025 before the US Supreme Court. As previously indicated, this is a much-politicized case brought by Mexico against US gun manufacturers. The hearing before the US Supreme Court took place on 4 March 2025. Estados Unidos Mexicanos (Mexico) No. We have previously reported on this case here and here.
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FDA Law Blog
FEBRUARY 26, 2025
Trusting suppliers is still fundamental to any drug or device manufacturer. And the Department of Justice will still pursue viable civil and criminal cases , if not under the FCPA then under other statutes like the False Claims Act, Title 18 fraud and conspiracy, and even RICO. So, yes, compliance and quality still matter, a lot.
FDA Law Blog
JULY 17, 2022
Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.
Constitutional Law Reporter
MARCH 4, 2025
.” The Fifth Circuit Court of Appeals has determined that a manufacturer may seek judicial review in that circuit even if it neither resides nor has its principal place of business there, so long as its petition is joined by a seller of its products, such as a gas station or convenience store, based in the circuit. Cunningham v.
FDA Law Blog
OCTOBER 4, 2021
In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. Earlier this year, the D.C. And just last year , the D.C. 6 to less than 17 years of age).
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”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
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