Praluent Safety Study Requirements: A Backdoor To Ensuring Outcomes Trial Completion?
Agency requires three post-marketing studies under the FDA Amendments Act's drug safety authorities; Sanofi says some of the requirements will be answered by data collected in the ongoing ODYSSEY OUTCOMES trial.
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Advisory committee sent a clear message that pre-exposure prophylaxis studies are needed in cisgender women, but what those studies might look like, and whether the agency can exercise its statutory authorities to ensure they are conducted, is less clear.
Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.