JURIST
APRIL 27, 2023
The EU Wednesday released a draft of its proposed overhaul of drug manufacturing laws. The changes have caused controversy among manufacturers, with some stating they will leave the region if the laws take effect. However, the changes sparked some pushback from the drug manufacturing industry.
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
MARCH 7, 2024
Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.
FDA Law Blog
AUGUST 13, 2023
Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e.,
LawSites
SEPTEMBER 21, 2023
market last December, today is announcing its expansion into contract drafting with the release of LegalOn Templates, a collection of more than 100 market-standard templates created and kept current by attorneys experienced in the applicable area of law. “We keep these updated for any changes in the law,” Shimamoto said.
Customs & International Trade Law
MARCH 15, 2022
On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two aforementioned government declarations. Whether the manufacturer plans to submit a marketing submission. contact information).
FDA Law Blog
DECEMBER 12, 2023
We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.) CVM explicitly states in the draft guidance that preventing one urolith type while potentially promoting formation of the other is not supportive of a general UTH claim.
Expert insights. Personalized for you.
197 
Let's personalize your content