Vial

MAY 20, 2024

between 2024 and 2030. One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate. billion in 2023 and is expected to grow at a CAGR of 7.0%

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Drug Target Review

SEPTEMBER 10, 2024

FDA no longer has to require animal testing for new drugs. 2024:24-26 About the authors Alejandro Fernandez Martell, Global Principal Scientist, Lonza Alejandro is a Global Principal Scientist at Lonza with a main focus on Upstream Process Development. References: 1 Wadman M. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al.

Drug Development 65

Drug Development Clinical Supply Production Protein Expression 65

Agency IQ

JANUARY 26, 2024

BY LAURA DIANGELO, MPH | JAN 23, 2024 12:15 AM CST Orthopedic, implanted medical devices and coatings: Regulatory recap Medical device materials, and coating: In general, the types of materials and components of which medical devices are constructed need to be evaluated for their impact on a device’s performance and safety. What’s next?

FDA 40

FDA Animal Testing Packaging Regulations 40

Agency IQ

JANUARY 12, 2024

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. The final rule is expected in April 2024. BY PATRICIA ISCARO, ESQ. |

Animal Testing 40

Animal Testing Regulations Production Marketing 40

Agency IQ

MARCH 7, 2024

BY SCOTT STEPHENS, MPA | MAR 7, 2024 8:21 AM CST The format: an emphasis on conversations ECHA’s one-day event , titled “Shaping Tomorrow,” was held at the agency’s headquarters in Helsinki, Finland and live-streamed on ECHA’s website. Among the topics: stakeholder cooperation in the context of the green and digital transition.

Regulations 40

Regulations International Government Compliance 40

Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Finally, MDCG 2024-3 outlines the expected content for a clinical investigation plan and MDCG 2024-5 describes the content of the investigator’s brochure.

Trials 40

Trials Marketing Clinical Trials Disease 40

Agency IQ

JANUARY 19, 2024

BY RAYAN BHARGAVA, MSC | JAN 11, 2024 6:55 PM CST Regulatory background A 2019 fitness check of the most relevant chemical regulations found that protection afforded to human health and the environment was of a suitably high standard, although issues with consistency and efficiency were evident.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

Animal Testing 40

Animal Testing Regulations Production Research 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. Online June 27, 2024. Credit: Neumann EN, Bertozzi TM, et al. Paper cited: Neumann EN, Bertozzi, TM et al.

Disease 142

Disease Therapies Clinical Trials Engineering 142

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research 125

Research Engineering Disease Science 125

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

PLOS: DNA Science

APRIL 4, 2024

.” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” It debuted in January 2024 , but the company has been around since 2015. ” Manufacturers can use existing safety data on each ingredient and on similar products.

Disease 85

Disease Testimonials Production FDA 85

Codon

JUNE 2, 2024

” It’s an uncharitable take, but when drugs fail as often as they do despite animal testing, it’s not hard to see the JAX mice as a metaphor for a biomedical enterprise cloistered away from the real world. ” Asimov Press (2024). Cite this essay: Alex Telford. “The Mouse as a Microscope.”

Laboratories 138

Laboratories Research Disease Science 138

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.

Regulations 40

Regulations FDA Science Production 40

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

Animal Testing 59

Animal Testing FDA Analytical Chemistry International 59