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Food and Drug Administration (FDA) China Prescription Drugs

McGuireWoods LLP

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

McGuireWoods LLP on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

Cozen O'Connor

Cozen Currents: Casting Trump II: The Sequel

Cozen O'Connor on

The Cozen Lens- •A second Trump administration would likely include both familiar faces from his first term and newcomers, but a lack of institutional guardrails means that former President Trump’s personnel choices will be...more

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

Goodwin on

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Wilson Sonsini Goodrich & Rosati

China Patent Linkage System

Starting in July of this year, China initiated a patent registration platform that bears some similarity to the generic drug framework under the Hatch-Waxman Act in the U.S. The purpose of this alert is to describe this new...more

Perkins Coie

Updates on the Implementation of the Newly Amended PRC Patent Law

Perkins Coie on

The China National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) in the People’s Republic of China (PRC) issued measures to facilitate the implementation of the newly...more

McDermott Will & Schulte

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Robins Kaplan LLP

Financial Daily Dose 10.1.2019 | Top Story: Credit Suisse COO Resigns in Wake of Corporate Spying Scandal

Robins Kaplan LLP on

Top Tidjane Thiam ally Pierre-Olivier Bouee, Credit Suisse’s COO, has resigned in the wake of an internal probe finding that he “ordered the surveillance of the bank’s former wealth-management chief, Iqbal Khan, without...more

Goodwin

Biosimilar Development Updates: BOTOX, RITUXAN, EYLEA

Goodwin on

Below are some highlights of recent news in biosimilar development: Earlier this week, Mylan and Revance Therapeutics, who are collaborating in developing a biosimilar of BOTOX (onabotulinumtoxinA), reported on their...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

K&L Gates LLP on

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

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