Drug Discovery World

FEBRUARY 2, 2023

It does not eliminate animal testing for drugs nor does it state or imply that animal testing is unnecessary. Ultimately, the FDA Modernization Act 2.0 may not materially change the current drug approval process at the FDA. appeared first on Drug Discovery World (DDW).

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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.

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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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Drug Discovery World

JANUARY 21, 2024

It is enabling computational protein design for vaccine immunogen discovery, and high-throughput and high-definition assays for quicker and more comprehensive characterisation of vaccine candidates and vaccine-elicited immunity. “Technology plays multiple roles in all stages of vaccine development,” says Kanekiyo. “It

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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.

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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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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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