Codon

NOVEMBER 1, 2024

” Nobody really knows without trying it out in the laboratory. Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. Subscribe to Asimov Press. There are a few reasons.

DNA

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. This also has clear potential to reduce animal testing, another key commitment made by the Commission.

Packaging

Drug Target Review

SEPTEMBER 10, 2024

Rapid delivery of IND-enabling Tox testing is crucial for a timely IND submission Advanced technologies enabling increasingly rapid timelines from vector construction to good manufacturing practice (GMP) manufacture brings the prospect of ever shorter timelines to IND readiness. FDA no longer has to require animal testing for new drugs.

Drug Development

Agency IQ

JUNE 7, 2024

Like the registration requirement under REACH, this provision has been added to support data sharing for the same substances, to help limit potential data gaps among individual companies and, in turn, decrease the need for resorting to animal testing.

Regulations

Agency IQ

JUNE 28, 2024

Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. Some of these are laboratory and animal tests, cadaveric studies and data from similar devices.

Trials

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. However, with a strong therapy design and promising laboratory results in hand, the researchers have good reason to be hopeful.

Disease

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.

FDA