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.

Manufacturing 59

Manufacturing Patient-Centered Government Hospital 59

FDA Law

JULY 17, 2022

Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. Refunds will be payable for single-dose container drugs beginning on January 1, 2023.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

MARCH 29, 2024

Many have noted that FDA has been slow to recover We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program.

Clinic 59

Clinic IT Manufacturing Government 59

FDA Law

JANUARY 5, 2023

It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. HHS would then use MRAP scores in the proposed Hospital Resilient Supply Program (HRSP).

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

OCTOBER 17, 2023

The new guidance also presents an opportunity for device manufacturers working for patient populations affected by rare life-threatening or irreversibly debilitating diseases or conditions, such as sickle cell disease. By Philip Won & Lisa M.

Medical 53

Medical Diagnosis Healthcare Clinic 53