Animal Testing and Definition - Drug Discovery Digest

Animal Testing

Definition

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animal testing not eliminate animal testing in drug development. adequate to justify the proposed clinical testing.” The pre-existing statutory language did not require animal testing.

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

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

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. Does this guidance offer the formal definition of “orphan device” we’ve been waiting for?

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Bridging Innovation & Patient Care: The Growing Role of AI

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Ceracare

The Pharma Data

MAY 15, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! Ceracare is a natural supplement containing powerful antioxidants that help support detoxify your body and support blood sugar. And always following good manufacturing practice (GMP) guidelines.

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Bridging Innovation & Patient Care: The Growing Role of AI

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Unity

The Pharma Data

MAY 14, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! Unity is a natural supplement containing powerful antioxidants that help support detoxify your body and support weight loss. Unity gathers the freshest and highest quality natural ingredients available.

Production

Production Animal Testing Doctors Testimonials

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

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FDA Science Small Molecule Immune Response

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

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Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

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. BY PATRICIA ISCARO, ESQ. |

Animal Testing

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Raising Welfare for Lab Rodents

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.

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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 Commission unveils “one substance, one assessment” reform package

Agency IQ

JANUARY 19, 2024

The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation. This also has clear potential to reduce animal testing, another key commitment made by the Commission.

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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

billion in “definite user fees.” Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 the Congressionally funded portion of the FDA’s total budget) level. billion includes ~$3.5

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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

Here, the draft guidance states that the appropriate timing for an INTERACT meeting should be when a sponsor has identified a specific product and has conducted some preliminary proof-of-concept (POC) studies but has not yet designed and conducted definitive toxicology studies.

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

Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. It’s also interesting to see what isn’t on this list.

Regulations

Regulations FDA Science Production

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

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

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Ceracare

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Unity

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

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

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Raising Welfare for Lab Rodents

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

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

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

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

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

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