A Guidance on Premarket Pathways for Combination Product in the United States of America

نویسندگان

چکیده

The Office of combination products OCP, an agency to regulate the under US Food and Drug Administration (FDA) has released final guidance on for its approval which is named “Principles Premarket Pathways Combination Drugs,” provides FDA’s current strategies into market. guideline, comparable draft notification issued in February 2019, emphasizes specifies five particular instances those techniques apply.

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ژورنال

عنوان ژورنال: International journal of pharmaceutical investigation

سال: 2022

ISSN: ['2230-9713', '2230-973X']

DOI: https://doi.org/10.5530/ijpi.2022.4.70