2010 Manufacturing Patients Provider 
My Green Doctor
MAY 3, 2025
The breadth of services provided by modern day medicine is profound. Innovative surgeries, novel pharmaceuticals, and state of the art technology are just a few of the driving forces that have aided the delivery of exceptional care to patients across all specialties. tons in the United Kingdom each year. 3 “Each U.S.
My Green Doctor
MAY 3, 2025
This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. The breadth of services provided by modern day medicine is profound. Dilating and anesthetic eye drops are routinely offered to patients in most ophthalmology clinics.
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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.
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. Last week, the U.S.
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
SEPTEMBER 11, 2023
This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,
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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