JURIST
DECEMBER 20, 2022
The UN CBD is set to assess information from these reports by late February 2026 and again in June 2029. The UN CBD deal compliments the recently published draft agreement on climate change from the COP27 climate summit in November. That draft, unlike Monday’s agreement, has yet to be finalized. degrees Celsius. degrees Celsius.
FDA Law Blog
DECEMBER 23, 2024
Although such designations are not typically a prerequisite for a voucher, the law is drafted so that once this first sunset date has passed, only designated programs may receive priority review vouchers for rare pediatric diseases until the program sunsets completely.
FDA Law Blog
DECEMBER 3, 2023
Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively.
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