JD Supra December 26, 2022
Week in Review Highlight of the Week:
This week, Congress passed the 2023 omnibus funding package ahead of the December 23 deadline and HHS released ownership data for all Medicare-certified hospitals. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On December 21, 2022, FDA issued draft guidance entitled, Controlled Correspondence Related to Generic Drug Development. This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify...
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