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Guidance for industry [[electronic resource] ] : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications



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Titolo: Guidance for industry [[electronic resource] ] : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications Visualizza cluster
Pubblicazione: Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2009]
Descrizione fisica: 1 online resource (36 pages)
Soggetto topico: Drugs - Risk assessment - Government policy - United States
Biologicals - Risk assessment - Government policy - United States
Note generali: "Draft guidance."
"Drug safety."
"September 2009."
Altri titoli varianti: Guidance for industry
Titolo autorizzato: Guidance for industry  Visualizza cluster
Formato: Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione: Inglese
Record Nr.: 9910699112203321
Lo trovi qui: Univ. Federico II
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