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 ...

“FDA has not changed its position that currently available clinical trial data do not demonstrate ... were interfering with their ability to practice medicine by overstepping their authority ...

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

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 ...

Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and stand-alone flu inoculation, sending shares down sharply. The vaccine ...

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 ...