Government Healthcare Manufacturing Provider 
FDA Law
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).
FDA Law
MARCH 24, 2024
By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).
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FDA Law
NOVEMBER 30, 2022
According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.
My Green Doctor
MAY 3, 2025
Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health. 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.
FDA Law
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).
FDA Law
MAY 7, 2025
Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Medicare or Medicaid).
FDA Law
NOVEMBER 6, 2022
In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.
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