Policy Prescription

MARCH 11, 2022

It’s important because this case was wrongly used as a pretext to oppose safe personal drug importation and international online pharmacies, which help Americans afford prescription drugs. clinics in 2011. The Winnipeg Free Press has an excellent story on that. Kris Thorkelson never pled guilty to selling counterfeit drugs.

Online Pharmacies 52

Online Pharmacies Pharmacy FDA International 52

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.

Compliance 105

Compliance Drugs Pharmacy Licensing 105

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.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

MAY 26, 2023

2011), aff’d , 741 F.3d You never need an authorization from a licensed professional to buy pork or fireworks. They can regulate doctors, pharmacies, and grocery stores, but cannot ban an FDA-approved drug like they can pork that comes from pigs not raised in a specific way, the gist of the California law at issue in NPP.

Regulations 59

Regulations Production FDA FDA Approval 59

Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. Sorsaia , 2023 WL 3211847, at *2. Its] FDA approval allows it to sell mifepristone nationwide. . . . [T]he T]he growing market for mifepristone. . .

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

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. 2d 397 (6th Cir.

FDA 59

FDA FDA Approval Testimonials Vaccine 59