Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

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DNA RNA Molecular Biology Laboratories 132

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations.

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Therapies FDA Production Disease 59

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. The draft guidance helpfully adds a few examples of appropriate Type D meeting scenarios, and they are: A specific question about an aspect of a complex or innovative trial design (e.g.,

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FDA Packaging Animal Testing Production 64

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. The guidance notes that all approaches should be justified.

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Broad Institute

JUNE 27, 2024

The first problem they had to tackle was the editor’s size, because the editor needs to be small enough to be packaged and delivered to specific cells in the body. From tool to drug Led by Neumann and Bertozzi, the researchers began engineering a new epigenome editor.

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Disease Therapies Clinical Trials Engineering 142

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

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FDA Packaging Science Drugs 40

Codon

MARCH 14, 2023

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. There are even differences in how their genomic DNA is packaged inside of neurons. Free-range mice?

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DNA Laboratories Animal Testing Engineering 52