regulation

US Food and Drug Administration commissioner Margaret Hamburg is stepping down after six years on the job.

While some drugs sail through development, others suffer setbacks, including FDA rejections, before reaching the market.
 

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

This year in life science was marked by paltry federal funding increases, revelations of sequence contamination, and onerous regulations.

A new agreement in the European Union allows genetically engineered crops to be approved without member-state votes, likely allowing several GMO foods to enter the market.

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.

The US government releases its policy on so-called dual-use research involving dangerous pathogens that could be used for biological terrorist attacks.

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

Did 20th-century pharmaceutical and technological advances shape modern sexual behaviors?

Four new documents from the US Food and Drug Administration provide industry with guidelines on the use of nanotechnology in products regulated by the agency.

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.

Most stem cell lines registered with the NIH don’t comply with the FDA’s guidelines for human use, according to a new report.  

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.

Another personal genomics company faces government pressure—this time from the Federal Trade Commission.

The company announces that it will stop offering health interpretations of personal genetic data.

Tracks and Shadows, The Gap, The Cure in the Code, and An Appetite for Wonder

The European Medicines Agency has recommended that farmers stop using the antibiotic colistin prophylactically, citing human health concerns.

A newly instated patent law discriminates against academics and small biotechs.