HIMA (US Health Industry Manufacturers Association) petitions FDA over use of data contained in early marketing applications
This article was originally published in Clinica
The US Health Industry Manufacturers Association (HIMA) has filed a citizen petition with the FDA urging the agency to stop using data contained in premarket approval applications (PMAs) made before the passage of the FDA Modernization Act in 1997 (FDAMA) when approving PMAs filed by competitors.
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