When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshal
Rezensionen / Stimmen
"The only complete, single source available...the book provides an understanding of drug development and manufacturing regulations in the United States and how a company may comply with them."
--Anticancer Research
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für Beruf und Forschung
Regulatory affairs professionals in pharmaceutical, food, and cosmetic companies; students; FDA personnel
Illustrationen
15 s/w Abbildungen, 23 s/w Tabellen
15 b/w images and 23 tables
Dateigröße
ISBN-13
978-1-4200-3783-8 (9781420037838)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility. Recalls: Corrections and Withdrawals. Civil Actions. Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity. Case Studies. Appendix 1.FD&C Act of 1938. Appendix 2.Drug Law History Synopsis. Appendix 3.Clinical Investigators. Appendix 4.FDA Administrative Procedures Act (FAPA). Glossary. Index.
