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Clinical Trials › Registration Requirement

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

BakerHostetler on

Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

Morgan Lewis

Overview of Medical Device Regulation in China

Morgan Lewis on

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more

Hogan Lovells

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Hogan Lovells on

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more

Hogan Lovells

Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday April 18 2017

Hogan Lovells on

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more

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