Animal Testing and Packaging - Drug Discovery Digest

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

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

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.

Disease

Disease Therapies Engineering Clinical Trials

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

FDA

FDA Packaging Animal Testing Production

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 Protein Expression

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

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The draft guidance recommends that no more than 15 questions are included in the briefing package.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. The draft guidance states that a pre-BLA meeting request should be submitted at least 4 months before the anticipated BLA submission.

Therapies

Therapies FDA Production Disease

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

Agency IQ

JANUARY 26, 2024

Shelf life and packaging: The guidance offers information on what FDA reviewers would need to see related to shelf life testing in two areas: sterility and device/coating function. Clinical performance testing: Generally, clinical studies are not necessary for metallic and calcium phosphate coated devices.

FDA

FDA Animal Testing Packaging Regulations

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

Agency IQ

AUGUST 18, 2023

This framework is anchored in the Classification, Labeling, and Packaging Regulation (CLP) (1272/2008/EC), the bloc’s definitive legislation on classifying substances and mixtures. European Union The E.U. Currently, the CLP is aligned with parts from the sixth and seventh revised editions of the GHS.

International

International Regulations Packaging Animal Testing

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

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

Regulations Animal Testing Production Marketing

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

Agency IQ

MARCH 7, 2024

Hojsik, a member of EP’s Renew Europe group, highlighted the revision of the regulation on the classification, labeling and packaging of chemicals (CLP) and its inclusion of new hazard classes as an important achievement over the past five years.

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

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. . Ceracare is a natural supplement containing powerful antioxidants that help support detoxify your body and support blood sugar. Therefore, we strongly recommend you take advantage.

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. . Unity is a natural supplement containing powerful antioxidants that help support detoxify your body and support weight loss.

Production

Production Animal Testing Doctors Testimonials

Everything Wrong with Mouse Studies (Kinda)

Codon

MARCH 14, 2023

Mice raised at five different animal facilities in Europe, under otherwise identical conditions , have “persistent differences in body weight” and behavior. There are even differences in how their genomic DNA is packaged inside of neurons. Each animal had a different microbiome. Nobody really knows why.

DNA

DNA Laboratories Engineering Animal Testing

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

Levers for Biological Progress

Codon

NOVEMBER 1, 2024

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. This essay focuses on how we might do both, specifically for the cell. Subscribe to Asimov Press.

DNA

DNA RNA Molecular Biology Laboratories

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

Origins of the Lab Mouse

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

Laboratories Research Disease Science

Drug Discovery Digest

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

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

Trending Sources

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

Rapid delivery of toxicological material

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

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

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

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

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

Ceracare

Unity

Everything Wrong with Mouse Studies (Kinda)

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

Levers for Biological Progress

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

Origins of the Lab Mouse

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