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Cozen O'Connor

FDA Transparency Push: CRLs Released

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On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

King & Spalding

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

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On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

McDermott Will & Schulte

McDermott HealthEx 2025: McKinsey Key Takeaways

McDermott HealthEx convened more than 1,300 of the most influential leaders in healthcare and life sciences. The event emphasized creativity, transformation, and growth, with sessions dedicated to innovation, AI-powered...more

McGuireWoods LLP

Insights From the 21st Annual McGuireWoods Healthcare Private Equity and Finance Conference: Part 1

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McGuireWoods held its 21st Annual Healthcare Private Equity and Finance Conference in Chicago, May 13-15, 2025. This premier conference brought together leading healthcare investors, lenders, executives, consultants and...more

McDermott Will & Schulte

Investment Opportunities in TechBio and Pharma Services - European Health & Life Sciences Symposium 2025

In April 2025, McDermott once again hosted its annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

McDermott Will & Schulte

European Health & Life Sciences Symposium 2025: Key Takeaways

In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

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The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more

Morgan Lewis - As Prescribed

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more

McDermott Will & Schulte

Pharma and MedTech Services Investment Summit 2024

The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

McDermott Will & Schulte

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

McDermott Will & Schulte

[Webinar] Investing In Clinical Trial Site Management Organizations: Key Regulatory and Diligence Considerations - April 17th,...

Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations. Investing in pharma services is complicated, but our team...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2020

Jones Day on

Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

McDermott Will & Schulte

[Event] 3rd Annual Shanghai Life Sciences Forum - November 12th, Shanghai, China

McDermott Will & Schulte on

MWE China Law Offices and its strategic alliance partner McDermott Will & Emery are proud to co-host our annual Shanghai Life Sciences Forum in partnership with the Redefining Early Stage Investments (RESI) conference. This...more

McDermott Will & Schulte

[Event] 2019 Hospital & Health System Innovation Summit - October 24th, New York, NY

McDermott Will & Emery’s Hospital & Health System Innovation Summit will prepare innovation leadership teams to address the business, regulatory compliance and legal challenges they may face when navigating innovation efforts...more

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