Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). The pharmacy prompt payment requirements from the CGDP will also apply to the Discount Program.

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Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. OTC drugs also have an express preemption provision, but it contains an exception for Prop 65.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. 2011), aff’d , 741 F.3d Ogden , 22 U.S. Wisconsin , 228 U.S. 115 (1913), and Savage v. Jones , 225 U.S.

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Drug & Device Law

MAY 19, 2023

In 2011 (during the Obama Administration), the FDA completed the REMS for mifepristone, mandating that it “only be prescribed by certified physicians, dispensed in certain healthcare facilities, and taken in the provider’s clinic.” Sorsaia , 2023 WL 3211847, at *2. Its] FDA approval allows it to sell mifepristone nationwide. . . . [T]he

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Drug & Device Law

FEBRUARY 20, 2023

223, 238 (2011), the United States Supreme Court reacted to a plaintiff’s unconstrained claims of “alternative” vaccine design: [T]he [design] decision is surely not an easy one. In at least the short term, a popular pain reliever would have to be removed from pharmacies. In Bruesewitz v. Wyeth LLC , 562 U.S. at 164 (quoting Wolfe v.

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