Good Clinical Practice (GCP), the bedrock of ethical and ... However, like other aspects of drug development, it is evolving. The International Council for Harmonisation of Technical Requirements ...

Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice ...

The FDA has lifted clinical holds on trials of zevor-cel, satri-cel, and CT071, and trials will now resume in the US.

Clinical research is overseen by the FDA to ensure trials are designed, conducted, analyzed, and reported according to federal law and good clinical practice regulations. Clinical trials at Huntsman ...

By the end of 2024, the US Food and Drug Administration ... requiring sIRB review. It’s good news for everyone, even if it represents a shift in control from clinical trial sites to the industry ...

The "FDA Regulatory Compliance for Drug and Biotech Product Training Course" training has been added to ResearchAndMarkets.com's offering. This course will benefit professionals involved in working ...

A small clinical trial shows promising results for patients with triple-negative breast cancer who received an ...

Liquidia Corporation (NASDAQ:LQDA) Q3 2024 Earnings Call Transcript November 13, 2024 Operator: Good morning and welcome ...

BioNTech SE (NASDAQ:BNTX) has been notified by its partner, OncoC4 Inc., that the FDA has imposed a partial clinical hold on its Phase 3 PRESERVE-003 trial. The open-label, randomized study ...

New research points to taking melatonin 3 hours before bedtime but some experts say it is still best to take the supplement ...