Refine your search

Content type
Tags
Firm name
Author
Jurisdiction
Language

1,215 results found

Article
Ask Lexy

Reed Smith LLP | USA | 20 Sep 2022

Ninth Circuit Finds No Private Cause of Action Against Pharmaceutical Compounder

It has been just about two years since the Central District of California dismissed the claims in Nexus Pharmaceuticals, Inc. v. Central Admixture…
Article
Ask Lexy

Sidley Austin LLP | USA | 29 Aug 2022

Unprecedented Changes to Medicare Programs Leave Many Questions Unanswered for Pharmaceutical Manufacturers

Earlier this month, President Biden signed into law the Inflation Reduction Act of 2022 (Act), which includes sweeping changes to the Medicare…
Article
Ask Lexy

Duane Morris LLP | USA | 4 Aug 2022

FDA Issues Guidance on the Background and Evaluation of Therapeutic Equivalence Codes

In July 2022, FDA published guidance to industry regarding its therapeutic equivalence evaluations, including the assignment of therapeutic…
Commentary
Ask Lexy

Baker McKenzie | USA | 3 Aug 2022

Patent linkage in the United States: key considerations for drug manufacturers

"Patent linkage" is generally understood to be the practice of linking the granting of marketing approval or any other regulatory approval for a generic or biosimilar medicinal product to the status of a patent for the originator reference product. The concept of patent linkage is a contentious issue in the healthcare industry as it concerns the involvement of drug authorities with patent......
Article
Ask Lexy

Covington & Burling LLP | USA | 5 Jul 2022

A Closer Look: Express Federal Preemption for OTC Medications Subject to Monographs

Manufacturers of over-the-counter (OTC) medications often move to dismiss consumer class actions based on federal preemption. The Federal Food, Drug…
Article
Ask Lexy

Duane Morris LLP | USA | 27 Jun 2022

DOJ Clarifies Position on Fraud-on-the-FDA Theory of False Claims Act Liability

On June 3, 2022, the Washington, D.C., office of the Civil Division of the Department of Justice (DOJ) filed a statement of interest in a relator's…
Article
Ask Lexy

Sidley Austin LLP | USA | 9 Jun 2022

DOJ Defends Viability of Fraud-on-the-FDA Theory in Statement of Interest

Over the past decade, relators have attempted to expand the long-established “fraudulent inducement” theory of liability into a novel…
Article
Ask Lexy

McGuireWoods LLP | USA | 1 Jun 2022

In the Weeds: FDA Warns Against CBD for Food-Producing Animals, Okla. Suspends Lab License, Calif. Launches Cannabis Access Map

FDA Continues CBD Warnings; Sends Letters to Companies Selling CBD Products for Food-Producing Animals. On May 26, 2022, the U.S…
Article
Ask Lexy

Formosan Brothers | Taiwan | 1 Jun 2022

專利新修法期將深化我國專利連結法律制度

2019年8月20日,我國「藥事法」增訂第四章之一專利連結專章正式生效,為完善我國專利法制得進一步與國際接軌,2022年4月15日,…
Article
Ask Lexy

Hogan Lovells | USA | 18 May 2022

FDA Cites Five Companies for Illegally Selling Delta-8 THC and CBD Products

The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol…
Previous page 1 2 3 ...