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Regulatory Procedures Manual 2009
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 Regulatory Procedures Manual March 2007 Edition


 Department of Health and Human Resources


 Food and Drug Administration


 Office of Regulatory Affairs


 Office of Enforcement


 with images of FDA Badges and FDA Centennial 1906 through 2007.

RPM Introduction (PDF PDF Document, 27 kb)
RPM Chapter 1 (PDF PDF Document, 307 kb)
RPM Chapter 2 (PDF PDF Document, 288 kb)
RPM Chapter 3 (PDF PDF Document, 734 kb)
RPM Chapter 4 (PDF PDF Document, 272 kb)
RPM Chapter 5 (PDF PDF Document, 467 kb)
RPM Chapter 6 (PDF PDF Document, 726 kb)
RPM Chapter 7 (PDF PDF Document, 404 kb)
RPM Chapter 8 (PDF PDF Document, 154 kb)
RPM Chapter 9 (PDF PDF Document, 13 kb)
RPM Chapter 10 (PDF PDF Document, 138 kb)
RPM Chapter 11 (PDF PDF Document, 147 kb)
RPM Appendix (PDF PDF Document, 25 kb)


The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

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