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Research and Development Regulatory Oversight Life Sciences

Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Lathrop GPM

Trump Executive Order Restricts Funding for “Dangerous Gain-of-Function Research”

Lathrop GPM on

On May 5, the Trump administration issued Executive Order 14292, “Improving the Safety and Security of Biological Research,” which effectively ends federal funding for “dangerous gain-of-function research” and other life...more

Hogan Lovells

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

Hogan Lovells on

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more

Hogan Lovells

New scientific data rules in China: China claims "data sovereignty"

Hogan Lovells on

In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of government-funded scientific...more

Hogan Lovells

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

Hogan Lovells on

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

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