2010 Clinic IT Manufacturing 
FDA Law
MAY 30, 2024
Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.
My Green Doctor
MAY 3, 2025
Dilating and anesthetic eye drops are used routinely to treat patients in most ophthalmology clinics. The standard of care worldwide in clinics is to use multidose eyedrop bottles — meaning there is enough medicine one bottle to treat many patients. The product manufacturers and vendors will need to be active partners as well.
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My Green Doctor
MAY 3, 2025
In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.
FDA Law
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
APRIL 3, 2023
By way of background, manufacturers are subject to an additional per-unit Medicaid rebate if they increase their prices greater than the rate of inflation. Vanda is also conducting clinical studies of a long-acting injectable form of its marketed drug Fanapt tablets, an anti-seizure drug. NDA or BLA) drugs. NDA or BLA) drugs.
FDA Law
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
SEPTEMBER 11, 2023
Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.
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