Target Health Resources

Regulatory

Form FDA 483 - Myths and Misunderstandings

April 1, 2014

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Regulatory
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Article

Nobody wants to receive a Form FDA 483 after an FDA inspection of a clinical site, drug/device company, manufacturing plant or other entities subject to regulatory inspections. Nevertheless, while inspection findings are inevitable, they are not intended to be "the end of the world."

A Novel Enzyme Replacement Therapy for Gaucher Disease

November 1, 2011

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Regulatory
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Article

Target Health, Inc. participated in study design, regulatory activities, and data management, and reviewed all versions of the manuscript for this clinical trial.

The Critical Path Initiative Meets Medical Device

March 1, 2007

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Regulatory
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Article

Interaction is high on FDA’s list of ways to improve the development and review process for technologies.

FDA Relations During Drug Development

September 14, 2000

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Regulatory
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Article

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs.

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