SCOTUSBlog
SEPTEMBER 29, 2023
The question comes to the court in the case of George Sheetz , who in 2016 applied for a permit to build a 1,854-square-foot manufactured home on land that he owns in Placerville, California. The post Twelve cases added to Supreme Court calendar appeared first on SCOTUSblog. Additional orders from the Sept. 2, at 9:30 a.m.
At the Lectern
MARCH 13, 2024
The Supreme Court yesterday announced it will hear six oral arguments in April, tying last week’s argument session as the biggest calendar of the term. One case involves UC Berkeley’s controversial plan to build student housing at People’s Park. More about the case here.
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FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.
FDA Law Blog
APRIL 8, 2024
For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”
FDA Law Blog
JUNE 3, 2021
Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. By Serra J. See our previous coverage of such state laws here , here and here.) North Dakota.
FDA Law Blog
JANUARY 1, 2024
Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.
FDA Law Blog
SEPTEMBER 12, 2021
This new law requires prescription drug manufacturers to report the current wholesale acquisition cost (WAC) information for drugs sold in or into the state on a quarterly basis. The new law also requires manufacturers to submit WAC price increase reports and new drug WAC reports.
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