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 ...

The FDA has published its long-awaited update to guidance to make sure clinical trials more closely reflect the range of patients that might be treated with a new therapy in the real world.

Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice ...

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 ...

“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 vaccine maker on Wednesday said the Food and Drug Administration placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant ...

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 ...