article thumbnail

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

FDA Law Blog: Drug Discovery

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.

article thumbnail

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

Agency IQ

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?

Trials 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Join DDW for the SLAS2024 Ignite Theater ‘Innovation from lab to patient’

Drug Discovery World

Inspired by the overall event theme of ‘Innovation at Every Turn’, the DDW track will present leading research and case studies from experts in academia, government agencies and the industry on how technology is innovating from bench to bedside, lab to patient. It is sponsored by Integra Biosciences and Hamamatsu Corporation.

Vaccine 130
article thumbnail

What does the FDA animal testing legislation mean for drug discovery? 

Drug Discovery World

ends a federal mandate that experimental drugs need to be tested on animals before they can be used in human clinical trials 2. As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. The Modernization Act 2.0

article thumbnail

Ceracare

The Pharma Data

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! You should do your own research and confirm the. Ceracare is a natural supplement containing powerful antioxidants that help support detoxify your body and support blood sugar.

article thumbnail

Unity

The Pharma Data

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! You should do your own research and confirm the. Unity is a natural supplement containing powerful antioxidants that help support detoxify your body and support weight loss.

article thumbnail

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

Agency IQ

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. |