Sentences with phrase «final study drug»

And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and throughout the study period and for 180 days after the final study drug administration.

• Female subject must agree not to breastfeed at Screening and throughout the study period and for 60 days after the final study drug administration.

• Female subject must not donate ova starting at Screening and throughout the study period and for 180 days after the final study drug administration.

Not exact matches

Last year, the FDA issued final guidance on the use of real - world data for the development of devices, and FDA Commissioner Scott Gottlieb has pledged to issue guidance on real - world data for both pre-and post-marketing drug studies.

The NAPOLI - 1 (NAnoliPOsomaL Irinotecan) Phase 3 study — a final confirmation of a drug's safety and effectiveness — was conducted among patients with metastatic pancreatic cancer who previously received gemcitibine, which has been the standard - of - care therapy for such patients.

During her final two years at the agency, she had directed the Lab of Antiviral Drug Mechanisms, where she studied therapies for AIDS as well as one of its associated cancers, Kaposi's sarcoma.

The move could also spell relief for Amicus Therapeutics and CEO John Crowley, who personally lobbied the president on the FDA's decision to delay any final decision on their drug for Fabry disease so they could see the results of a safety study in 2019.