Day: September 16, 2021

Biodistribution studies are needed for gene therapy products usually early on for better interpretation of the pharmacological and toxicological effects of the product, but these can be conducted under non-GLP conditions and use animal tissues specimens combined over multiple non-clinical studies. The new ICH guidance endorsed by the FDA this week provides several commonsense measures … Read more

FDA reversed its decision regarding the inadequacy of a small Phase 2 trial for the approval of a new drug for ALS under pressure from patient groups setting up yet another precedence for other similar developers of drugs for rare diseases with questionable data. Accepting this market approval application will set FDA to being forced … Read more