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It’s About Time: FDA’s Proposed Rule to Amend Prior Notice Regulations

FDA Law Blog: Biosimilars

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. The FDA Food Safety Modernization Act (FSMA) enacted in 2011, aims to ensure the U.S. By Sophia R. Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S.

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Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

BY RACHEL COE, MSC Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data.

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Malaria unravelled: decoding the parasite’s gene expression control

Drug Target Review

Researchers from Tokyo Tech’s World Research Hub Initiative conducted a study to investigate the regulation of gene expression in the apicoplast of the malaria parasite Plasmodium falciparum. How is melatonin, the circadian signalling hormone, related to the regulation of gene expression in the apicoplast?

RNA 98
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Scientists generate new targeted protein degradation system that tunes a cell’s own proteins

Broad Institute

In the new study, the researchers used a system called phage-assisted continuous evolution (PACE), first developed in Liu’s lab at Harvard in 2011, to generate a degron that might work with PT-179. Continuous evolution of compact protein degradation tags regulated by selective cereblon molecular glues. Paper cited Mercer JAM, et al.

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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog: Biosimilars

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. Thus, the Agency concluded, the June 2011 date should stand. On August 8, 2024, the Court granted Nissan et al.’s

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Analysis Chemical Thank You The 103 regulations the EPA is currently working on

Agency IQ

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Analysis Chemical Thank You Supreme Court significantly expands time to file lawsuits over agency regulations

Agency IQ

Supreme Court significantly expands time to file lawsuits over agency regulations The Supreme Court has issued its opinion in Corner Post v. In the Dodd-Frank Act, the Federal Reserve was tasked with exploring a cap on interchange fees, and it published Regulation II in 2011 , which set a maximum fee of $.021