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An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
For further perspectives on events highlighted in timeline, see this article (Also see "US FDA's Decade In Review: From Biosimilars To Real-World Evidence" - Pink Sheet, 15 Jan, 2020.)
Pink Sheet: global policy and regulatory coverage
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
Pink Sheet: global policy and regulatory coverage
By Brenda Sandburg 16 Feb 2020
Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based...
Pink Sheet: global policy and regulatory coverage
By Brenda Sandburg 16 Feb 2020
First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district...
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