2025 Manufacturing Statute 
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.
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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).
Customs & International Trade Law
DECEMBER 27, 2024
We look forward to working with you in 2025! As we wrap up this extraordinary year, we want to take a moment to thank you for your trust, collaboration, and support. This year was marked by significant milestones and meaningful accomplishments, including saving our clients MILLIONS of dollars.
FDA Law Blog
SEPTEMBER 14, 2021
Beginning in 2025, payment for certain “Selected” single source drugs under Parts B and D, and under commercial plans that do not opt out of the program, would be limited to a Maximum Fair Price (MFP). In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.
Expert insights. Personalized for you.
105 
Let's personalize your content