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FDA Drug Approval: Elements and Considerations: Elements & Considerations (Pharmacology-research, Safety Testing and Regulation) - Hardcover

 
9781622570911: FDA Drug Approval: Elements and Considerations: Elements & Considerations (Pharmacology-research, Safety Testing and Regulation)
Hardcover
ISBN 10: 162257091X ISBN 13: 9781622570911
Verlag: Nova Science Publishers Inc, 2012

Inhaltsangabe

The Food and Drug Administration (FDA) oversees the approval and regulation of drugs entering the U.S. market. Two regulatory frameworks support the FDA's review of prescription drugs. First, FDA reviews the safety and effectiveness of new drugs that manufacturers wish to market in the United States; this process is called pre-market approval or pre-approval review. Second, once a drug has passed that threshold and is FDA-approved, FDA acts through its post-market or post-approval regulatory procedures. This book is a primer on drug approval and regulation. It describes how drugs are approved and come to market, including the FDA's role in that process and the FDA and industry roles once drugs are on pharmacy shelves.

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Verlag
Nova Science Publishers Inc
Erscheinungsdatum
2012
Sprache
Englisch
ISBN 10 
162257091X
ISBN 13 
9781622570911
Einband
Gebundene Ausgabe
Auflage
1
Anzahl der Seiten
142
Herausgeber
King Timothy I., Baker Thomas R.
Kontakt zum Hersteller
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Verantwortliche Person
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