FDA

The FDA writes that failure to immediately cease sales of unapproved versions of mifepristone and misoprostol may result in action.

The government has never fined anyone for breaking a law about reporting clinical trials. A new effort is trying to change that.

The study looked at recently approved major changes to critical devices such as blood-sugar monitors, stents, and defibrillators meant to restart the heart.

An independent panel of scientists make a case for "opioid exceptionalism."

Endo Pharmaceuticals appears to be preparing its opposition to the FDA's request.

Gottlieb is a partner at a venture capital firm, New Enterprise Associates, which invests in drugs that may come before the FDA for approval.

Consumer genetic tests like 23andMe aren't medical devices, and the FDA shouldn't regulate them like blood-sugar meters or pregnancy tests.

Testing prescription drugs on pregnant women is controversial. It's also utterly necessary if we care about the health of both mother and child.

A meta-study finds "female Viagra" to have low-to-moderate benefits and side effects.

The scientific evidence for whether eating too much sugar causes Type 2 diabetes and other diseases.

Key parallels and important distinctions.

University of California–San Francisco researcher Cristin Kearns dropped a promising career at the Kaiser Foundation to dig through sugar industry archives for a smoking gun. With help from the man who brought down Big Tobacco, she’s now proving that Big Sugar steered scientists away from looking at the ingredient’s harmful effects.

An early look at a Pacific Standard story that's currently only available to subscribers.

The Food and Drug Administration's approval of a pharmaceutical treatment for low sexual desire in women has launched a heated debate over the dangers and benefits of medicalizing sex.

Placed in historical perspective, the popular opposition to things like GMOs and vaccines, much like 19th-century opposition to fertilizers and insecticides, reflects less an overt rejection of science than a distrust of experts who peddle it.

An early look at a Pacific Standard story that's currently only available to subscribers.

As much as we would love over-the-counter pills, here's an argument for why we should treat birth control like any other drug.

Too often, doctors aren't using sound science when they prescribe a drug for unapproved uses, a new study finds.

A bill that would speed up approval for medications and medical devices shows how a major initiative can get traction even in the midst of Washington gridlock—but critics say all the lobbying is drowning out some warnings about patient safety.

Internal company documents that have emerged in a New Jersey trial make clear that marketing for Tylenol did not convey doctors’ concerns about its risks.

Essure, the latest malfunctioning medical device, shows us exactly what’s wrong with the way medical devices are approved in this country.

Court filings from a new lawsuit describe a previously unreported lobbying campaign by McNeil Consumer Healthcare to block tougher regulation.

Top Chef judge Tom Colicchio has issued his verdict: We need safer, healthier food right now—and everyone deserves a place at the table.

New research suggests consumers completely misinterpret on-package nutrition information.