The FAA is seeking public comments on proposed guidance that would define sample sizes for parts manufacturer approval (PMA) applicants seeking certification for engine and auxiliary power unit (APU) ...
The FDA has formally accepted for filing Ondine Biopharma 's premarket approval (PMA) application for the Periowave photodisinfection system for treating chronic periodontitis in adults as an adjunct ...
Fourth and final module of the PMA submitted in June Supportive analyses included in final module of the PMA meet both of the pre-specified co-primary endpoints in the AUDACITY Study NATICK, ...
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer (CRC) that avoids some of the issues with alternative diagnostic methods.
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