FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. and OPKO Ireland Ltd.

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

Production 78

Production Insulin Branding Generic Drugs 78

XTalks

AUGUST 2, 2023

AbbVie has also had some approvals made for their drugs, such as the European Commission approval of Skyrizi (risankizumab) and another FDA approval of Vraylar (cariprazine) , which marks the fourth indication for Vraylar, this time as an adjunctive therapy to antidepressants for major depressive disorder. billion in 2022. billion, a 6.00

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41