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image: How the Pediatric Laws Work

How the Pediatric Laws Work

By | March 1, 2012

The Pediatric Research Equity Act (PREA) of 2003 requires that companies developing new drugs that could be used to treat a condition in children perform clinical trials in kids before winning FDA approval. 

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image: Tricky Trials

Tricky Trials

By | March 1, 2012

Studies on safety, efficacy, or dosing of drugs in children, or on nutritional supplements, are not run-of-the-mill.

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image: FDA's Biosimilars Guidance

FDA's Biosimilars Guidance

By | February 13, 2012

The federal agency finally breaks out some information on what it might take to get generic biological drugs approved.

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image: FDA Staffers Sue Agency

FDA Staffers Sue Agency

By | February 6, 2012

Current and former employees of the US Food and Drug Administration have filed suit, alleging that their employer spied on them for whistleblowing.

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image: A Bill to Expedite Drug Production

A Bill to Expedite Drug Production

By | February 2, 2012

Legislation proposes speeding certain drug applications submitted to the US Food and Drug Administration.

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image: Novel Cystic Fibrosis Drug Approved

Novel Cystic Fibrosis Drug Approved

By | February 1, 2012

After a lightning-fast approval, the first medicine to treat an underlying cause of the disorder hits the market.

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image: The Breast Implant Risk

The Breast Implant Risk

By | January 26, 2012

Breast implants leaking contaminated silicone are causing a fuss in Europe, but all breast implants carry risks.

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image: Drug Approvals Up for 2011

Drug Approvals Up for 2011

By | January 9, 2012

The FDA approved 30 drugs last year, the highest number in the last 7 years.

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image: FDA Curbs Livestock Antibiotics

FDA Curbs Livestock Antibiotics

By | January 6, 2012

The agency has limited the use of antibiotics in farm animals.

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image: Clinical Trial Data Repressed

Clinical Trial Data Repressed

By | January 5, 2012

A new study finds that important drug safety data are not seeing the light of day.

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