Trial Design

New Guidance on Developing Drugs Under the Animal Rule

Drugmakers conducting animal trials to support the development of biological and chemical weapon countermeasures should control for animal age, health, weight and physical environment when designing study protocols, the FDA says in draft guidance implementing the Animal Efficacy Rule. Read More

FDA Draft Guidance Addresses Demonstration of Biosimilarity

Manufacturers of biosimilars should take extra care in designing clinical trials and executing other steps needed to demonstrate that their products line up with reference drugs, according to key FDA draft guidance on creating versions of the complex therapies. Read More

FDA Finalizes Guidance on Ensuring Smooth Transfer of IRBs

Institutional review boards (IRBs) that assume oversight of a clinical trial from another IRB should give drugmakers an opportunity to address any concerns the receiving IRB has with the study before it is terminated or suspended, the FDA says in a final guidance that makes only minor tweaks to the 2012 draft. Read More