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Megan Moynahan

About Megan Moynahan

U.S. Food and Drug Administration - FDA
Website: http://www.fda.gov/ Type: Government Country: United States About: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Recent Contributions

Megan Moynahan replied to "Malaria RDT Expert Panel SESSION 3: Assessment, Procurement and Financing" in the Malaria Treatment & Prevention community.

Here is Dr Poole's response to the second question, What are challenges to successful implementation? FDA Response: Some challenges to successful implementation are: 1) inadequate laboratory training of users 2) tests developed in US were not evaluated under conditions present in developing countries. e.g., extreme temperatures, power outages, contamination in ...
Megan Moynahan replied to "Malaria RDT Expert Panel SESSION 3: Assessment, Procurement and Financing" in the Malaria Treatment & Prevention community.

Here's Dr Poole's reply to the first question: In order for a malaria RDT to be distributed in the U.S. premarket clearance is required. Malaria RDTs have been classified under 21CFR 866.3402 as "Plasmodium species antigen detection assays", Class II devices. A description of these devices can be found in ...
Megan Moynahan replied to "Malaria RDT Expert Panel SESSION 3: Assessment, Procurement and Financing" in the Malaria Treatment & Prevention community.

I'd like to provide FDA's comment to the first question, but first I'd like to introduce the subject matter expert who provided the information to me: Freddie M. Poole, MS, is the Associate Director of the Division of Microbiology Devices in the Office of In Vitro Diagnostic Devices, and supervises ...

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