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Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated… Click to show full abstract
Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog.
Keywords:
value target;
regulatory value;
product profile;
target;
target product
Journal Title: Trends in biotechnology
Year Published: 2017
Link to full text (if available)
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Journal Title: Trends in biotechnology
Year Published: 2017
Link to full text (if available)
Share on Social Media: Sign Up to like & get
recommendations!