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image: How Drugs Interact with a Baby’s Parts

How Drugs Interact with a Baby’s Parts

By | March 1, 2012

A lot changes in a child’s body over the course of development, and not all changes occur linearly: gene expression can fluctuate, and organs can perform different functions on the way to their final purpose in the body. Here are some of the key deve

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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

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image: Child-Proofing Drugs

Child-Proofing Drugs

By | March 1, 2012

When children need medications, getting the dosing and method of administration right is like trying to hit a moving target with an untried weapon.

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image: Skin-Deep Immunity

Skin-Deep Immunity

By | February 29, 2012

Immune cells in skin provide powerful protection against infection, suggesting new routes for vaccination.

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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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