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Research and Development › New Guidance › Clinical Trials

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Knobbe Martens on

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

Health Care Compliance Association (HCCA)

‘No More Boutique Studies’: NIH Mulls ‘Stopping Rules,’ Other Changes to Improve Clinical Trials

Health Care Compliance Association (HCCA) on

At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more

Perkins Coie

FDA Releases Guidance on Clinical Research into Cannabis-Derived Drugs

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Health Care Compliance Association (HCCA) on

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Morgan Lewis

FDA Issues Guidance on Expanded Access

Morgan Lewis on

The Agency improves the process for access to investigational drugs and biologics for patients who lack other options. On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more

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