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2 Oct 2023, 8:26 pm by Kurt R. Karst
In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e., its rarity, its seriousness or life-threatening nature, and its unmet medical need) inform how much uncertainty the FDA will accept in terms of what constitutes an adequate and well-controlled trial (see Section V of that guidance available here). [read post]
26 Sep 2023, 2:30 pm by Dennis Crouch
Blue Cross Blue Shield of Mich., 825 F.3d 299, 305 (6th Cir. 2016). [read post]
23 Sep 2023, 7:21 pm by Bill Marler
State laboratories can send STEC cultures to the CDC to determine the serotype. [read post]
On September 1, 2023, Governor Newsom signed legislation that extends California’s restrictions on non-compete agreements to contracts signed out of state, effective January 1, 2024. [read post]