regulation, clinical trials

As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.

Although scientists debate the ethics of deliberately infecting volunteers with SARS-CoV-2, plenty of consenting participants have been exposed to all sorts of pathogens in prior trials.

The sponsors of upwards of 1,000 clinical trials may be forced to publish data that have gone unpublished over a 10-year period.

The watchdog website FDAAA TrialsTracker names and shames human studies that breach the FDA’s requirements for reporting results.

What can be done to lower development costs and drug prices?

In the midst of a debate about an experimental drug’s early approval, the US Food and Drug Administration requests that full trial results be released.

The Institute of Medicine says results from human clinical trials ought to be made available to independent researchers within 18 months.

Ebola, MERS, and enterovirus D68; polio eradication efforts; new regulations on potentially dangerous research

A draft policy from the US National Institutes of Health suggests that clinical studies performed at multiple sites should be reviewed by a single institutional review board.

There are no FDA-approved drugs to treat low sexual desire in women, but not for lack of trying.

Early Neanderthal evolution; developing antivirals to combat polio; the mouth and skin microbiomes; insect-inspired, flight-stabilizing sensors

After finally getting their hands on full clinical study reports, independent reviewers say the antiviral drug is ineffective.

More than a third of US drug approvals are based on a single large clinical trial, while others require more in-depth study, according to a new report.

A Swiss-based firm may have a back-door way to thwart a bioterrorist attack—by fighting the flu.