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Medical Devices › Regulatory Agencies › Compliance

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz - Health Care Viewpoints on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

Hogan Lovells

CRO Engagement: A compliance checklist to identify red flags and prevent bribery compliance risks

Hogan Lovells on

The engagement of Clinical Research Organizations (CROs) by pharmaceutical and medical device companies to manage some or all of their clinical trial-related duties and functions is becoming more and more relevant as the...more

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