FDA Wants Post-Approval Studies to Address Broader Public Health Needs

Posted 20 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is preparing a workshop to focus on the design and appraisal of studies conducted after the approval of a product to obtain further evidence of its safety or effectiveness.

The studies, otherwise known as post-approval studies (PAS), are often used when there are outstanding questions regarding a product. Many products that receive accelerated approval from US regulators, for instance, must conduct PAS because their initial approval is conditional upon the completion of larger Phase III studies. Other products, such as those identified by regulators as having potential cardiovascular risks, may be required to conduct more extensive Phase IV clinical trials that can involve thousands of patients.

FDA said its PAS workshop will focus exclusively on those required for class III medical devices approved through its premarket approval pathway. Class III devices are typically those deemed to have the highest potential to harm patients or those lacking sufficient information to determine the safety of the device.

PAS for class III devices are focused on specific questions, and FDA notes the studies must be, "Well-designed, scientifically sound, meaningful and feasible, and must provide complete and timely information." In its Federal Register posting, FDA said it hopes to discuss the role of PAS within the total product lifecycle and best practices used in conducting the studies.

Leveraged Studies

Regulators said they are also looking into how the studies might be leveraged to support the needs of other stakeholders such as public health groups. "In addition to the direct role of PMA holders, the role of other public health partners is expanding, as evidenced by a number of efforts external to CDRH that are directly or indirectly involved in collecting and analyzing data relevant to estimating medical device use and risk and in communicating risk to target populations," FDA wrote.

FDA's Center for Devices and Radiological Health (CDRH) said it hopes to start a dialogue at the workshop to ensure the development of, "Studies that maximize the public health impact by producing data that is informative to a range of stakeholders."

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