Animal Testing, FDA and Protein Expression

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Animal Testing

FDA

Protein Expression

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

Relatively recently, the concept of non-animal studies for toxicology data generation has been discussed and Food and Drug Administration (FDA) guidance in this direction was issued in December 2022. 1 The concept of in-silico models as surrogate for animal models is also an option for drug developers to generate initial safety data.

Drug Development

Drug Development Clinical Supply Production FDA

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., Where vector presence is detected, transgene mRNA and/or protein expression levels should also be measured.

Therapies

Therapies FDA Production Disease

Drug Discovery Digest

Rapid delivery of toxicological material

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

Stay Connected