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. Sections 5 – 9 are labeled as Part A and cover clinical evaluation considerations.

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Agency IQ

JUNE 7, 2024

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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Regulations Animal Testing Production Marketing 40

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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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. |

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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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The Pharma Data

MAY 15, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! Christine Brown is a pen name used for marketing purposes and to protect the author’s identity. Ceracare gathers the freshest and highest quality natural ingredients available. Actor portrayal.

Production 52

Production Animal Testing Doctors Testimonials 52

The Pharma Data

MAY 14, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! Andrew Hunter is a pen name used for marketing purposes and to protect the author’s identity. Unity gathers the freshest and highest quality natural ingredients available. Actor portrayal.

Production 52

Production Animal Testing Doctors Testimonials 52