Posted by Michael Wonder on 16 Nov 2018
Statement by FDA Commissioner Scott Gottlieb on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
16 November 2018 - The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, we require evidence from premarket clinical trials that the medicine will be both effective and safe for use when prescribed according to its labelling.
However, it’s not unusual for the FDA to identify issues that need additional evaluation either at the time of initial approval or later, once the drug has been marketed. These issues are evaluated through the conduct of additional post-marketing studies.
These post-approval studies are vital to enhancing patient safety and public health. They may be needed to further characterise the use of the product in the therapeutic armamentarium.
