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Entreprise · 19/09/20051 min de lecture
Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Extension of Application and Comment Deadlines
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Résumé
The Food and Drug Administration (FDA) is announcing an extension in the deadlines for submitting requests to participate in and comment on a pilot program involving the submission of chemistry, manufacturing, and controls (CMC) information consistent with the new pharmaceutical quality assessment system.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →