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European Union › Food and Drug Administration (FDA) › Clinical Trials

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - June 2024

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Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

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As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Arnall Golden Gregory LLP

[Webinar] The Long and Winding Road: (Some) EU and FDA Issues to Consider With Clinical Trials and Clinical Agreements - September...

Arnall Golden Gregory LLP on

Please join AGG Food & Drug co-chair Alan G. Minsk and Taylor Wessing Life Sciences and Healthcare attorneys Dr. Manja Epping and Irina Rebin for a complimentary webinar exploring the regulatory landscape of clinical trial...more

Venable LLP

Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar...

Venable LLP on

On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Hogan Lovells

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

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. In today’s report...more

Bass, Berry & Sims PLC

FDA Issues Updated Guidance on Clinical Trial Conduct during the COVID-19 Pandemic

Bass, Berry & Sims PLC on

Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more

Butler Snow LLP

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Goodwin

Samsung Bioepis Presents New Biosimilars Data at EULAR 2016

Goodwin on

At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from...more

Searcy Denney Scarola Barnhart & Shipley

Putting Testosterone to the Test

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Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

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