Animal Testing, Packaging and Research

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

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

Packaging Regulations Laboratories Animal Testing

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package. FDA no longer has to require animal testing for new drugs. References: 1 Wadman M.

Drug Development

Drug Development Clinical Supply Production FDA

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Agency IQ

AUGUST 18, 2023

BY RAYAN BHARGAVA, MSCAUG 16, 2023 10:33 AM CDT International: World Health Organization The International Agency for Research on Cancer (IARC) classification framework is particularly well-known , consisting of four levels of increasing certainty regarding human cancer risk. European Union The E.U.

International

International Regulations Packaging Animal Testing

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Bridging Innovation & Patient Care: The Growing Role of AI

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Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Agency IQ

JANUARY 26, 2024

Further, the agency issued guidance in 2021 on peripheral vascular atherectomy devices that focused, in part, on concerns about coating integrity (and coating particulate testing), and has contracted research on long-term effects of other coating materials.

FDA

FDA Animal Testing Packaging Regulations

Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

Regulations

Regulations International Government Compliance

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

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

Trials Marketing Clinical Trials Disease

A therapy candidate for fatal prion diseases turns off disease-causing gene

Broad Institute

JUNE 27, 2024

There are currently no treatments, but researchers from the Whitehead Institute for Biomedical Research and Broad Institute of MIT and Harvard have developed an approach that could one day be used to turn off the gene encoding this protein throughout the brain to treat or even prevent prion disease.

Disease

Disease Therapies Clinical Trials Engineering

Ceracare

The Pharma Data

MAY 15, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! of our 3 or 6 bottle discount package. . You should do your own research and confirm the. Ceracare gathers the freshest and highest quality natural ingredients available.

Production

Production Animal Testing Doctors Testimonials

Unity

The Pharma Data

MAY 14, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Therefore, we strongly recommend you take advantage of our 3 or 6 bottle discount package. . You should do your own research and confirm the. And always following good manufacturing practice (GMP) guidelines.

Production

Production Animal Testing Doctors Testimonials

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

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

FDA Packaging Science Drugs

Everything Wrong with Mouse Studies (Kinda)

Codon

MARCH 14, 2023

Mice and rats account for 95 percent of all animals used in biomedical research. For every 5,000 drug compounds tested in mice, five move into human studies. Mice raised at five different animal facilities in Europe, under otherwise identical conditions , have “persistent differences in body weight” and behavior.

DNA

DNA Laboratories Engineering Animal Testing

Origins of the Lab Mouse

Codon

JUNE 2, 2024

It took another five years for a pair of American researchers to come up with an explanation before going on to pioneer the mouse as biomedicine’s premier model organism. At that time, even though animal breeders had long exploited regularities in the patterns of inheritance, the principles underlying heredity remained mysterious.

Laboratories

Laboratories Research Disease Science

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

For example, the FDA does not have a proposed rule listed that would change how it regulates animal testing requirements following the passage of the FDA Modernization Act 2.0 It’s also interesting to see what isn’t on this list. provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022.

Regulations

Regulations FDA Science Production

Levers for Biological Progress

Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. Still, many of the bottlenecks slowing biology today are biophysical , rather than computational.

DNA

DNA RNA Molecular Biology Laboratories

Drug Discovery Digest

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Rapid delivery of toxicological material

Webinars

Trending Sources

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Webinars

Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

A therapy candidate for fatal prion diseases turns off disease-causing gene

Ceracare

Unity

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Everything Wrong with Mouse Studies (Kinda)

Origins of the Lab Mouse

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Levers for Biological Progress

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