FDA

Roughly 1 in 10 infants were born prematurely in the U.S. in 2018, according to the Centers for Disease Control and Prevention. The drug Makena is widely prescribed to women at high risk of going into labor early, though the latest research suggests the m

Drug To Prevent Premature Birth Divides Doctors, Insurers And FDA Experts

11:23am January 24, 2020

by Emmarie Huetteman

An expert panel convened by the FDA says the drug Makena should be withdrawn from the market because a review of its effectiveness shows it doesn't work. But OB-GYNS who prescribe the drug disagree.

The Food And Drug Administration reviews new drugs for approval much faster than it used to, but changes in the agency's standards have drawn questions.

Health & Safety

FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find

11:45am January 14, 2020

by Sydney Lupkin

Changes in the way the Food and Drug Administration reviews new medicines means that there are more cures and treatments on the market. But there's also less proof the drugs are safe and effective.

Kratom products are legal in most states and are widely available. But the federal Food and Drug Administration and the Drug Enforcement Administration worry that kratom carries the risk of physical and psychological dependency and, in some people, addict

Health & Safety

The Kratom Debate: Helpful Herb Or Dangerous Drug?

5:26pm January 13, 2020

by Lesley McClurg

Some people struggling with opioid addiction who switched to kratom swear the herb salvaged their lives. But federal agencies and the brother of a man who died from his kratom use warn of its risks.

Queue Listen Now

Politics & Government

Minimum Tobacco Buying Age Now 21 Nationwide

5:27pm December 30, 2019

by Paul Garber

A new law sets the nationwide minimum age to buy tobacco products at 21.

Even as the popularity of e-cigarettes exploded — with unknown health risks — the federal government was slow to regulate vaping companies.

Health & Safety

How Vaping Snuck Up On Regulators

11:34pm November 15, 2019

by Jim Zarroli

Even as the popularity of e-cigarettes like Juul has exploded — with unknown health risks — the federal government has been slow to regulate vaping companies.

Queue Listen Now

A large study published in late October found that weekly injections of Makena during the latter months of pregnancy "did not decrease recurrent preterm births."

Health & Safety

Controversy Kicks Up Over A Drug Meant To Prevent Premature Birth

6:35pm November 04, 2019

by Patti Neighmond

An expert panel wants the Food And Drug Administration to withdraw its approval for Makena, because a large study shows the drug doesn't work. But some doctors say the evidence isn't clear-cut.

Already, Health Canada has posted safety and efficacy data online for four newly approved drugs; it plans to release reports for another 13 drugs and three medical devices approved or rejected since March.

Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA

2:18pm October 11, 2019

by Barbara Mantel

The U.S. Food and Drug Administration treats most data it gets on the development of new drugs and medical devices as confidential to companies. Critics say making the data public would help patients.

A network of reproductive rights advocates is working to share information about self-induced abortion, both in person and over the Internet.

With Abortion Restrictions On The Rise, Some Women Induce Their Own

10:25pm September 19, 2019

by Sarah McCammon

Activists are spreading information about self-induced abortion online and in person. The World Health Organization says a single drug, misoprostol, can be used to safely induce abortion.

Queue Listen Now

President Trump speaks to the press with first lady Melania Trump and Acting Food and Drug Administration Commissioner Norman Sharpless (left) and Health and Human Services Secretary Alex Azar in the Oval Office at the White House on Wednesday.

Health & Safety

FDA To Banish Flavored E-Cigarettes To Combat Youth Vaping

11:47pm September 11, 2019

With hundreds of unexplained cases of vaping-related illness, and the sharp rise in youth vaping, the Trump administration is acting to crack down on kid-friendly vape flavors.

Queue Listen Now

Dr. Rebecca Gomperts says the government has seized abortion drugs she has prescribed from overseas to patients in the U.S. The drugs are approved by the FDA to induce abortion under a doctor's direction.

European Doctor Who Prescribes Abortion Pills To U.S. Women Online Sues FDA

5:03pm September 09, 2019

by Sarah McCammon

A federal lawsuit seeks to block the Food and Drug Administration from taking enforcement actions against a European doctor or her U.S.-based patients for prescribing or buying abortion pills online.