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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.

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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.

3 Comments

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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image: FDA Drafts Pharma Social Media Advice

FDA Drafts Pharma Social Media Advice

By | January 3, 2012

The agency releases draft guidelines on unsolicited questions about off-label use, but leaves many questions about social media marketing unanswered.

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image: HHS Overrules FDA on Plan B

HHS Overrules FDA on Plan B

By | December 10, 2011

Despite scientific evidence that Plan B emergency contraception is safe for women of all ages, the department of Health and Human Services declined to approve it for over-the-counter use.

3 Comments

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