Postmarketing Clinical Trials
Postmarketing study commitments are studies required of or agreed to by a sponsor that are conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. Agreements with sponsors to conduct postmarketing studies can be reached either before or after FDA has granted approval to a sponsor to market a product.
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Post Market Surveillance for Medical Devices
The Structure of Post Market Surveillance - US System - Complaints - QSR - International systems - Post Production Information Collection
The Structure of Post Market Surveillance - US System - Complaints - QSR - International systems - Post Production Information Collection
Why Pharmacovigilance (Phase IV Trials) will be increasingly seen: What do they tell us and why are they important?
Types of Phase IV studies - Safety Monitoring Plan - "rare" adverse event - value of a DMC in large studies - endpoints FDA is looking for
Types of Phase IV studies - Safety Monitoring Plan - "rare" adverse event - value of a DMC in large studies - endpoints FDA is looking for
Post-Marketing Strategies for Medical Devices - how to keep your device on the market
Primary triggers for FDA enforcement - effective compliance policies - when regulatory violations occur - how to respond to FDA about violations
Primary triggers for FDA enforcement - effective compliance policies - when regulatory violations occur - how to respond to FDA about violations
