Researchers Link Target Product Profiles to Shorter Review Times
By Michael Mezher -
Published 17 April 2017
A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.
Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration
Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP