FDA Law Blog: Biosimilars

MARCH 19, 2024

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. By Adrienne R.

Animal Testing 59

Animal Testing Laboratories Marketing Regulations 59

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

FDA 45

FDA Animal Testing Engineering Regulations 45

Codon

MARCH 14, 2023

” About 6% of all mouse genes are regulated in sex-specific ways. Each animal had a different microbiome. The FDA used to require animal tests before a human drug trial could proceed; they reversed that decision in January. .” Other scientists have said much the same thing since at least 2018.

DNA 52

DNA Laboratories Engineering Animal Testing 52

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

Animal Testing 59

Animal Testing FDA Analytical Chemistry International 59

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage.

Therapies 59

Therapies FDA Production Disease 59