A concise guide in plain English to how the US Food and Drug Administration operates in a practical manner regarding the approval of products in the three related industries. It is written for students, staff, and professionals at corporations, organizations, and schools and colleges who need quick and basic information. The topics include regulatory strategy; formatting, assembling, and submitting the New Drug Application; meeting with the Agency; biologics; medical device regulation; the development of orphan drugs; mood manufacturing practices and enforcement actions; electronic submissions; and the practice of regulatory affairs.

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