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. See Appendix III of MDCG 2020-6 for the suggested hierarchy of clinical evidence.]

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Trials Marketing Clinical Trials Regulations 40

Drug Discovery World

APRIL 12, 2023

Products and technologies such as cell-based assays, microphysiological systems and computer modelling will now all be regarded as suitable alternatives to animal testing in the early phases of drug development. The limitations of animal studies are widely documented. These points, coupled with the Modernization Act 2.0

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FDA Animal Testing Cell Based Assays Clinical Trials 130

Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. Nonclinical studies encompass much more than just animal studies.

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FDA Science Small Molecule Immune Response 40

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The draft guidance helpfully adds a few examples of appropriate Type D meeting scenarios, and they are: A specific question about an aspect of a complex or innovative trial design (e.g., In responding to meeting requests, FDA still reserves the right to determine what format is most appropriate.

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FDA Packaging Animal Testing Production 64

Codon

JULY 21, 2024

As I continued through the museum—which documents the intentional modification of life by humans—I recalled what the writer Hugh Raffles once said about how research animals “not only bear the burdens of our dreams of health and longevity but also assume the task of living out our nightmares.”

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Research Engineering Science Disease 119

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. This stage is more highly regulated and consists of both preclinical testing and clinical trials. Drug discovery and development is an arduous process that can cost upwards of $2.6 million USD.

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Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals 130

Agency IQ

MARCH 7, 2024

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 Next: Enriched Enrollment, Randomized Withdrawal (EERW) clinical trial designs.

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FDA Packaging Science Drugs 40