FDA Drug Approval: Elements and Considerations - Couverture rigide

 
9781622570911: FDA Drug Approval: Elements and Considerations
Couverture rigide
ISBN 10 : 162257091X ISBN 13 : 9781622570911
Editeur : Nova Science Publishers Inc, 2012

Synopsis

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
Nova Science Publishers Inc
Date d'édition
2012
Langue
anglais
ISBN 10 
162257091X
ISBN 13 
9781622570911
Reliure
Relié
Numéro d'édition
1
Nombre de pages
142
Éditeur
King Timothy I, Baker Thomas R
Coordonnées du fabricant
non disponible
Personne responsable
non disponible