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FDA

Antibiotic Limits Planned for Farms
Kerry Grens | Dec 11, 2013 | 2 min read
The Food and Drug Administration lays out a plan so that farmers will no longer use antibiotics to fatten up animals.  
23andMe Steps Back
Abby Olena, PhD | Dec 6, 2013 | 2 min read
The company announces that it will stop offering health interpretations of personal genetic data.
23andMe Now Facing Lawsuit
Kerry Grens | Dec 4, 2013 | 1 min read
Shortly after getting in trouble with the Food and Drug Administration, the personal genetic testing company is slapped with a class action lawsuit.
FDA Approves NGS Tests
Tracy Vence | Nov 21, 2013 | 1 min read
The agency has cleared marketing of four next-generation sequencing devices from Illumina.
A Hair-Raising Solution?
Dan Cossins | Sep 1, 2013 | 4 min read
In the long-fought battle against baldness, researchers are finally identifying molecular pathways that can be manipulated to generate new hair follicles.
FDA Considers Easing Controls on Diabetes Drug
Dan Cossins | Jun 11, 2013 | 2 min read
A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.
 
The Elixir Tragedy, 1937
Jef Akst | Jun 1, 2013 | 3 min read
A mass poisoning of 105 patients treated with an untested medication spurred Congress to empower the US Food and Drug Administration to monitor drug safety.
FDA to Regulate Fecal Transplants
Dan Cossins | May 21, 2013 | 2 min read
From now on, US physicians and researchers will have to get approval from the FDA before they can perform a stool transplant.
How Safe Is Your Medicine Cabinet?
Megan Scudellari | May 1, 2013 | 7 min read
After numerous high-profile safety scares, clinicians and regulators push to fix critical weaknesses in the FDA’s monitoring system for approved drugs.
FDA Reform to Boost US Economy?
Dan Cossins | Mar 5, 2013 | 2 min read
Two experts propose replacing Phase 3 trials with smaller, faster alternatives and post-market surveillance to invigorate the pharmaceutical industry.
Robo-Eye to Enter US Market
Bob Grant | Feb 11, 2013 | 1 min read
A retinal prosthesis, already available in Europe, can restore partial sight to people with a genetic disorder that causes blindness.
Stem-Cell Clinic Moves to Mexico
Dan Cossins | Feb 1, 2013 | 1 min read
A company offering experimental stem-cell treatments will carry out its procedures in Mexico after the FDA warned that it would need approval to operate in the U.S.
 
Opinion: Regenerating Safely
Dan Orlando | Jan 21, 2013 | 3 min read
Patient safety is paramount in regulating new stem cell treatments.
First Recombinant Flu Vaccine
Beth Marie Mole | Jan 21, 2013 | 1 min read
The US Food and Drug Administration approves the first flu vaccine made from recombinant proteins rather than a weakened virus.
Bones Get in Her Eyes
Dan Cossins | Dec 20, 2012 | 1 min read
After undergoing untested cosmetic surgery that uses stem cells to rejuvenate skin, a woman grew bone fragments in the flesh around one of her eyes.
Drug Approvals Up
Dan Cossins | Dec 7, 2012 | 1 min read
The total number of new drugs approved this year ties last year for the highest since 2004, suggesting that the pharmaceutical industry is recovering.
 
Hurry Up, FDA
Jef Akst | Dec 6, 2012 | 2 min read
The US Food and Drug Administration is taking steps to get new devices on the market sooner—and antibiotics may be next.
Call for Conflict Hub
Dan Cossins | Dec 3, 2012 | 2 min read
Biomedical groups propose a simplified system for the disclosure of potential conflicts of interests.
Uncloaking Clinical Trials
Beth Marie Mole | Oct 16, 2012 | 2 min read
Glaxo­SmithKline will share long-sought, raw trial data—but access will be tightly controlled.  
Drugmakers Question FDA's Integrity
Bob Grant | Sep 26, 2012 | 2 min read
Pharmaceutical and biotech companies ask the US Food and Drug Administration to ensure the independence of a third-party audit of its new drug program.
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