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Tag Archives: PMA
FDA Ups the Ante on Transparency
Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s … Continue reading
Posted in FDA, Industry News
Tagged 510(k), ANADA, ANDA, biologics, BLA, drugs, exclusivity, FDA, medical devices, NADA, NDA, patent, PMA, transparency
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FDA Implements FDAAA 2007 Pediatric Requirement for Device Applications
If our American way of life fails the child, it fails us all. – Pearl S. Buck The FDA recently announced that is implementing a requirement from the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) regarding medical … Continue reading
Posted in FDA, Industry News
Tagged FDA, FDAAA 2007, HDE, medical devices, pediatric, PMA
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