Government Hospital Manufacturing Patient-Centered 
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.
FDA Law
JULY 17, 2022
An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.
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FDA Law
JANUARY 5, 2023
To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
GeriPal
MARCH 2, 2023
The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.
GeriPal
DECEMBER 7, 2023
Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment. And that’s a good thing to share with an older patient or client that making decisions about your activity.
Physicians News Digest
APRIL 2, 2025
By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. Early last year, he had the colonoscopy at a hospital in Elmhurst, Illinois, not far from his home in Addison. Winard said the hospital declined the offer. Then the bill came.
FDA Law
SEPTEMBER 13, 2021
A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.
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