My Green Doctor
MAY 3, 2025
The breadth of services provided by modern day medicine is profound. A 2010 research study found that treating two patients per bottle instead of one would decrease plastic waste by approximately 12.69 The product manufacturers and vendors will need to be active partners as well. Eye 24 , 361–363 (2010). 3 “Each U.S.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
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My Green Doctor
MAY 3, 2025
The breadth of services provided by modern day medicine is profound. A 2010 research study found that treating two patients per bottle instead of one would decrease plastic waste by approximately 12.69 The product manufacturers and vendors will need to be active partners as well. Eye 24 , 361–363 (2010). 3 “Each U.S.
FDA Law Blog
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
FDA Law Blog
NOVEMBER 7, 2021
We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement.
FDA Law Blog
SEPTEMBER 29, 2021
The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.
FDA Law Blog
JULY 13, 2022
If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.
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