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FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding
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In Case You Missed It: Takeaways from Final Guidance for Submitting Pre-Launch Activities Importation (PLAIR) Requests to FDA for Drug Products Prior to Anticipated Approval | Wiley Rein LLP

The U.S. Food and Drug Administration (FDA or Agency) recently announced the final guidance titled “Pre-Launch Activities Importation Requests (PLAIR)” (Final Guidance). ....

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