Remove Animal Testing Remove Laboratories Remove Regulations
article thumbnail

Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects

FDA Law Blog: Biosimilars

using phantoms, ex vivo animal tissue models, and/or in vivo animal testing), computationally, and/or clinically. When in vivo animal testing is needed, tests should follow good laboratory practices and the animal model should be representative of the intended clinical application.

article thumbnail

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Most notably, preclinical research can be distinguished by their need for a series of extensive laboratory testing performed on non-human models, such as cell cultures and animals. Conclusion In conclusion, the roles of preclinical and clinical CROs are distinct but equally important in the drug development process.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

article thumbnail

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

Agency IQ

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Some of these are laboratory and animal tests, cadaveric studies and data from similar devices.

Trials 40
article thumbnail

Advanced 3D cell-based technologies

Drug Target Review

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

article thumbnail

The essential role of recombinant phage display antibody libraries

Drug Target Review

Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval. 3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. 2024 Jan 5;16(1).

article thumbnail

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. 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.