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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: Biota Babble

Biota Babble

By | March 1, 2012

Editor's choice in immunology

2 Comments

image: TB Screen Glows Green

TB Screen Glows Green

By | February 13, 2012

Infection by GFP-encoding viruses enables quick, easy detection of tuberculosis in patient samples.

2 Comments

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.

3 Comments

image: <em>C. diff</em> Infection Source Unclear

C. diff Infection Source Unclear

By | February 7, 2012

Only a quarter of Clostridium difficile infections in one hospital system were traced to contact with a symptomatic patient.

15 Comments

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: Federal Biosecurity Panel Speaks

Federal Biosecurity Panel Speaks

By | February 1, 2012

The US National Science Advisory Board for Biosecurity explains why it recommended redacting the details of studies reporting on a highly transmissible H5N1 strain.

6 Comments

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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