FDA Regulatory Affairs

<p>Examines harmonization of the US Federal Food Drug and Cosmetic Act with international regulations as they apply to human drug and device development research manufacturing and marketing. The <em><strong>Second Edition</strong></em> focuses on the new drug approval process cGMPs GCPs quality system compliance and corresponding documentation requirements. Written in a jargon-free style it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.</p><p><strong><em>FDA Regulatory Affairs</em></strong>:</p><ul> <ul> </ul> <li>provides a blueprint to the FDA and drug biologic and medical device development</li> <li>offers current real-time information in a simple and concise format</li> <li>contains a chapter highlighting the new drug application (NDA) process</li> <li>discusses FDA inspection processes and enforcement options</li> <li>includes contributions from experts at companies such as Millennium and Genzyme leading CRO’s such as PAREXEL and the Biologics Consulting Group and the FDA</li> <ul> </ul> </ul><p>Three all-new chapters cover:</p><ul> <ul> </ul> <li>clinical trial exemptions</li> <li>advisory committees</li> <li>provisions for fast track</li> </ul>