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. Read AgencyIQ’s analysis of those exemptions here.

Trials 40

Trials Marketing Clinical Trials Regulations 40

Broad Institute

JUNE 27, 2024

By Greta Friar, Whitehead Institute June 27, 2024 Images of a mouse brain show the effect of a technology called CHARM in turning off the expression of a gene in the brain. 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.

Disease 142

Disease Therapies Engineering Clinical Trials 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. increase in base salaries for federal workers in 2024, which started in January.

FDA 40

FDA Packaging Science Drugs 40

Codon

JUNE 2, 2024

At that time, even though animal breeders had long exploited regularities in the patterns of inheritance, the principles underlying heredity remained mysterious. That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages.

Laboratories 117

Laboratories Research Disease Science 117