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China Food and Drug Administration (FDA)

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Cozen O'Connor

Cozen Currents: Casting Trump II: The Sequel

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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

Mintz - ML Strategies

ML Strategies Outlook for 2024

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Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

Braumiller Law Group, PLLC

November 2023 Newsletter

In recent years, the global spotlight has illuminated the grave concerns surrounding human rights violations within China's Xinjiang region, particularly those impacting the Uyghur population. The Uyghur Forced Labor...more

Goodwin

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

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

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

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As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Holland & Knight LLP

Holland & Knight Health Dose: May 10, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Hogan Lovells

FDA updates on efforts to assist U.S. companies with China’s new food facility regulation

Hogan Lovells on

On October 22, 2021, the U.S. Food and Drug Administration (FDA) published an update on its efforts to assist US companies on China’s implementation of a new registration requirement for all food facilities importing foods...more

Akin Gump Strauss Hauer & Feld LLP

America’s Pharmaceutical Supply Chain: An Overview of the Policy Landscape and Potential Path Forward

For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 17

China Passes Major Data Protection Law as Regulatory Scrutiny on Tech Sector Intensifies - A final version of the law has not been published but a previous draft included rules around requiring consent for data protection...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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 15

Bye-Bye, Bitcoin: It's Time to Ban Cryptocurrencies - "International banking officials say cryptocurrencies such as bitcoin are speculative assets, not sustainable, usable money." Why this is important: This opinion piece...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

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 3

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In the Capitol: The U.S. Capitol was engulfed in chaos on Wednesday, as supporters of President Trump, responding to his call to head there, breached the complex, resulting in violence in the seat of America's federal...more

Harris Beach PLLC

FDA Limits Respirator Manufacturers who can Apply for Authorization Under EUA

Harris Beach PLLC on

The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 # 12

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In Washington - House Democrats postponed a planned Tuesday to vote on a bill to keep the government funded through 11 Dec. as talks resume with Republicans and the Trump administration....more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more

Seyfarth Shaw LLP

Chinese Manufacturers of Personal Protective Equipment Gave False U.S. Agent Information to Food and Drug Administration

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U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more

Wilson Sonsini Goodrich & Rosati

FDA Issues Revised EUA for Disposable Filtering Facepiece Respirators Manufactured in China

On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #7

Hogan Lovells on

In Washington: House Democrats unveiled the text of their massive $3 trillion “Phase 4” coronavirus stimulus package.  H.R. 6800, the “Health and Economic Recovery Omnibus Emergency Solutions Act” or the “The Heroes Act.”  ...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Revised EUA for Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China

On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National Institute...more

Seyfarth Shaw LLP

FDA Updates Emergency Use Authorization For Chinese Respirators

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Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more

ArentFox Schiff

New Clinical Data Not Encouraging for Chloroquine and Hydroxychloroquine as COVID-19 Treatment: FDA and NIH Expert Panel Speaks...

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The latest clinical data casts doubt on the safety and efficacy of these antimalarial drugs for treatment of COVID-19, and both the FDA and an Expert Panel of the NIH have just warned against their use outside of clinical...more

Goodwin

Biosimilar Market Updates

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Shanghai Henlius biosimilar antibody developments - On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products...more

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