Synagis: genotox, carcinogenicity and repro: done or skipped?

“Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.”

“Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.”

“Pregnancy Category C: Synagis® 110 is not indicated for adult usage and animal reproduction studies have not been conducted.”

“Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.”

“Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.”

“Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.”

“Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.”

“Studies on repeated dose toxicity, effects on the reproduction, embryo-foetal & perinatal toxicity, mutagenic potential, oncogenic/carcinogenic potential and ecotoxicity/environmental risk assessment were not considered necessary by the applicant and were not performed.”