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

FDA Law Blog

AUGUST 16, 2021

A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of the Hatch-Waxman Amendments in 1984, as FDA announced in the Federal Register last week.

Production 52

Production Drugs Generic Drugs Cosmetics 52

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

XTalks

AUGUST 2, 2023

In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. 2) Botox Therapeutic/Cosmetic Botox, or botulinum neurotoxin, is a neurotoxic protein produced by the Clostridium botulinum bacteria. in January 2023, according to the manufacturer.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

FDA Law Blog

JANUARY 1, 2025

The sponsors describe it as a safe harbor in a one-page explainer on the bill available here. More specifically, the bill states that these activities shall not be acts of direct, induced, or contributory infringement of a method of use claim in a patent listed in the Orange Book.

Cosmetics 105

Cosmetics Generic Drugs Branding Drugs 105

FDA Law Blog

MARCH 29, 2022

Koblitz — Legislation has been proposed in Congress that would require FDA to regulate all contrast agents as drugs even though two courts determined that doing so clearly contradicts the plain language of the Federal Food Drug and Cosmetic Act (“FDC Act”). Farquhar & Sara W. Court of Appeals for the D.C.

Regulation 40

Regulation Production Drugs Generic Drugs 40

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. for drug safety. counterparts. J)(2) Waiver authority.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41