Where is US FDA's overdue 'animal rule' guidance for drugs?
This article was originally published in SRA
The US Food and Drug Administration has been called on to explain when its long-overdue drug guidance on the so-called animal rule is likely to be finalized.
You may also be interested in...
FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.
US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.
Payers and prescribers, not just the US FDA, need to understand the basis of approval, John Rex says.