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June 13, 2024, Paper: "The United States Food and Drug Administration's (FDA's) Premarket Notification 510(K) pathway allows manufacturers to gain approval for a medical device by…
2023, Opinion: "Starting in 1992, the U.S. Food and Drug Administration (FDA) instituted the Accelerated Approval (AA) program allowing drugs that treat serious medical conditions…
August 1, 2023, Opinion: "In 1992, the Food and Drug Administration (FDA) initiated the Accelerated Approval Program to “allow for earlier approval of drugs that treat…