FDA

Sarepta Therapeutics was awarded a voucher for a fast-track drug review by the Food and Drug Administration when the company's medicine for Duchenne muscular dystropy was approved Sept. 19. Now Sarepta is looking to sell the voucher to the highest bidder.

Are Golden Tickets That Speed Drugs Through FDA Worthwhile?

2:16pm September 29, 2016

by Sarah Jane Tribble

A voucher awarded to a company that finds a treatment for a rare childhood disease can be sold to the highest bidder and then used to fast-track the review of another drug. Are the prizes worth it?

A Look At How The Revolving Door Spins From FDA To Industry

5:13pm September 28, 2016

by Sydney Lupkin

About 27 percent of Food and Drug Administration reviewers who approved hematology-oncology drugs from 2001 through 2010 left to work for the industry they previously regulated, an analysis found.

Duchenne muscular dystrophy patients Jack Willis (center), Nolan Willis (right) and Max LeClaire, attended the opening of Sarepta Therapeutics new headquarters in Cambridge, Mass., in 2014.

Controversy Continues Over Muscular Dystrophy Drug, Despite FDA Approval

8:59am September 24, 2016

by Richard Harris

The Food and Drug Administration approved a muscular dystrophy drug despite deeply flawed evidence. Was the decision a dangerous precedent or flexible pragmatism reflecting patients' values?

Researchers Question Safety, Value Of Untested Stem Cell Treatments

5:03am September 05, 2016

by Rob Stein

Clinics are using stem cells to treat problems ranging from arthritis and torn tendons to paralysis and stroke. But researchers say there's no evidence that the treatments work or are safe.

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Where are the generic alternatives to EpiPen and other expensive drugs that have lost patent protection?

FDA Fees On Industry Haven't Fixed Delays In Generic Drug Approvals

4:34pm September 01, 2016

by Sydney Lupkin

Four years after user fees were imposed to speed up the review of generic drug applications by the Food and Drug Administration, more than 4,000 generics remain in limbo.

All U.S. Blood Donations Should Be Screened For Zika, FDA Says

4:29pm August 26, 2016

by Joe Neel

The recommendations from the Food and Drug Administration represent a major expansion in testing blood for Zika. The agency had earlier advised testing only in areas with an active outbreak.

Containers hold genetically modified Aedes aegypti mosquitoes before being released in Panama City, Panama, in September 2014.

Florida Keys Opposition Stalls Tests Of Genetically Altered Mosquitoes

6:47pm August 17, 2016

by Greg Allen

The Food and Drug Administration has approved release of genetically engineered mosquitoes in an effort to halt the spread of Zika virus. But residents of the Florida Keys aren't keen on the concept.

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In 2015, the Sandoz unit of drugmaker Novartis won Food and Drug Administration approval of a drug called Zarxio, which is similar to Amgen's Neupogen, a medicine that boosts the production of white blood cells.

FDA-Approved Knock-Offs Of Biotech Drugs Could Safely Save Big Bucks

5:01pm August 01, 2016

by Alison Kodjak

Drugs that consist of proteins and antibodies typically made by living organisms represent the new frontier in drug industry competition.

An ad from the Food and Drug Administration's Fresh Empire campaign.

Notorious FDA? Feds Turn To Hip-Hop To Tamp Down Teen Smoking

12:01pm May 09, 2016

by Maanvi Singh

For its latest anti-tobacco campaign, the Food and Drug Administration wants to harness hip-hop swagger to reach minority teens — who disproportionately suffer the consequences of smoking.

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Politics & Government

FDA Releases New Regulations On E-Cigs, Other Tobacco Products

5:03pm May 05, 2016

by Sean Bueter

The federal government has released some long-awaited regulations for a variety of tobacco products, including electronic cigarettes.