FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.”

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Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

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Animal Testing Drugs Clinical Trials Clinical Research 105

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. This was confirmed in human trials and the drug was subsequently approved by the FDA.

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Animal Testing Disease Trials Research 147

The Pharma Data

MAY 15, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! FDA registered and GMP (good manufacturing practices) certified facility. offered by a physician or other licensed healthcare provider. And always following good manufacturing practice (GMP) guidelines.

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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! FDA registered and GMP (good manufacturing practices) certified facility. offered by a physician or other licensed healthcare provider. And always following good manufacturing practice (GMP) guidelines.

Production 52

Production Animal Testing Doctors Testimonials 52

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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Regulations FDA Science Production 40

Drug & Device Law

NOVEMBER 6, 2023

The FDA has taken recent steps that may, or may not, affect product liability litigation. Our interest in the FDA’s draft guidances is whether they undercut Lohr ’s statement about the §510(k) process – by demonstrating that, in administering it, the FDA actually is concerned about the safety of “substantially equivalent” devices.

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FDA Animal Testing Licensing Licensing 59