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US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information.
Ridge, Sarah; Guinn, Daphne; Pfuma Fletcher, Elimika; Zineh, Issam; Madabushi, Rajanikanth; Ramamoorthy, Anuradha.
Affiliation
  • Ridge S; Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Guinn D; Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pfuma Fletcher E; Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zineh I; Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Madabushi R; Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ramamoorthy A; Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, Maryland, USA.
J Clin Pharmacol ; 63(6): 695-703, 2023 06.
Article in En | MEDLINE | ID: mdl-36731882
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Full text: 1 Database: MEDLINE Main subject: Pharmacology, Clinical Limits: Humans Country/Region as subject: America do norte Language: En Journal: J Clin Pharmacol Year: 2023 Type: Article Affiliation country: United States
Fulltext
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Full text: 1 Database: MEDLINE Main subject: Pharmacology, Clinical Limits: Humans Country/Region as subject: America do norte Language: En Journal: J Clin Pharmacol Year: 2023 Type: Article Affiliation country: United States