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Medical Research › Biotechnology › Regulatory Oversight

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

BakerHostetler

Healthcare Industry Team 2023 Year in Review

BakerHostetler on

As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more

Nelson Mullins Riley & Scarborough LLP

Minimizing the Fallout from Increasing FDA Clinical Holds

Nelson Mullins Riley & Scarborough LLP on

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

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