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FDA

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Sep 30

How one drug company fast-tracked the FDA’s review process

By Sarah Jane Tribble, Kaiser Health News

Any company awarded a voucher can use it for a fast-track government review of one of its future drugs — or it can sell the voucher to another company.

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Sep 20

After fierce debate, FDA approves first drug for rare form of muscular dystrophy

By Liz Szabo, Kaiser Health News

The FDA, reacting to lobbying by patients and families, has approved a drug for Duchenne muscular dystrophy, a rare and lethal disease.

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Sep 11

FDA weighs crackdown that could shut hundreds of stem cell clinics

By Usha Lee McFarling, STAT

Scientists on Monday will urge the Food and Drug Administration to crack down on rogue clinics across the country that market stem cell treatments.

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Sep 10

Allergy-proof? Intelligence booster? FDA looks to rein in health claims for baby formula

By Sheila Kaplan, STAT

The FDA suggested this week that the $3 billion infant formula industry consider proving its claims before selling the products.

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Sep 09

FDA expresses concern over widely used ovarian cancer screening test

By Sheila Kaplan, STAT

The Food and Drug Administration on Wednesday warned women and their doctors that current screening tests for ovarian cancer are unreliable.

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Sep 02

Antibacterial soap may do more harm than good, FDA says

By Emily Wishingrad

Soaps and wash products labeled “antibacterial” can no longer be sold, the U.S. Food and Drug Administration announced Friday.

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Aug 26

Infant anti-gas medication linked to spread of hospital infections

By Chad Terhune, Kaiser Health News

A surprising ingredient — infant gas relief drops — may be contributing to the contamination of medical scopes nationwide.

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Jun 23

Compromise for GMO food labeling rules struck in Senate

By Mary Clare Jalonick, Associated Press

Senators have a bipartisan deal to require labeling of genetically modified ingredients nationally, a week before a labeling law in Vermont goes into effect.

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Jun 21

Federal panel approves first use of CRISPR gene editing in humans

By Sharon Begley, STAT

A federal biosafety and ethics panel on Tuesday unanimously approved the first study in cancer patients of the genome-editing technology CRISPR/Cas9.

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Jun 09

If FDA doesn’t issue faster food recalls, consumers face danger, watchdog says

By Ricardo Alonso-Zaldivar, Associated Press

Despite new legal powers to compel recalls and sophisticated technology to fingerprint pathogens, the Food and Drug Administration allowed some food-safety investigations to drag on, placing consumers in jeopardy of death or serious illness, according to the inspector general's office…

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