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image: Self-prescribing Patients?

Self-prescribing Patients?

By | March 13, 2012

The FDA considers making some drugs for diabetes, asthma, and other ailments available over the counter.

4 Comments

image: Are the Kids Alright?

Are the Kids Alright?

By | March 1, 2012

Two key pieces of legislation, enacted to spur drugmakers into testing pharmaceutical products in children, are up for reauthorization in the US Congress this October. Have they done their jobs?

6 Comments

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.

3 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: 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.

6 Comments

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.

0 Comments

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