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Chronic Condition

Government

Supply Chain

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law

JANUARY 9, 2024

The government would require at least another 30 days to examine the shipment at the U.S. Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. See 21 C.F.R. 251.5; § 251.6(c). See 21 C.F.R.

Supply Chain

Supply Chain Manufacturing Chronic Condition Government

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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