NIH Delays Basic Brain Research Rules

August 20, 2018

NIH has delayed a controversial new policy that would have required basic brain and behavioral researchers to treat their work as clinical trials.

FDA Suggests Endpoints for Opioid Treatments

August 13, 2018

Sponsors may not have to prove a proposed therapy helps addicts totally kick opioids to win FDA approval. But they will have to show it significantly cuts dependence on the potent pain meds, the agency says in new draft guidance.

WHO: Focus on Biosimilar Differences

August 6, 2018

Clinical trials of biosimilars should focus on how they differ from the drugs they copy rather than on creating a whole new safety or efficacy study, the World Health Organization says.

FDA Posts First List of Surrogate Endpoints

July 30, 2018

The FDA has published the first-ever list of surrogate endpoints, giving sponsors the first concrete suggestions for the kinds of laboratory measures or physical signs that might help develop drugs even when clinically meaningful data proves elusive.

New Guidance for Multiregional Clinical Trials

July 23, 2018

The FDA has issued new guidelines designed to help researchers navigate sometimes conflicting regional requirements and differences in global clinical trials in an effort to pave the way for better cooperation and faster international drug development.

New Report: Improving Clinical Site Payment Practices

July 23, 2018

Paying sites on time is critical to a trial’s success, sponsors agree, and most believe they’re making the grade. So why are sites so frustrated with how they’re paid? Are their expectations unreasonable or are sponsors operating in the dark?