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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
By Sue Sutter 16 Jul 2020
US FDA adds brucellosis, opisthorchiasis and paragonimiasis to the list of qualifying diseases but declines to include clonorchiasis and coccidioidomycosis...
Pink Sheet: global policy and regulatory coverage
By Brenda Sandburg 16 Jul 2020
Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate...
Pink Sheet: global policy and regulatory coverage
By Derrick Gingery 16 Jul 2020
US FDA could revoke orphan designation or exclusivity if cost recovery requirements were not satisfied under bill unanimously passed by...
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