Background Generic drug products demonstrate BE to the (brand name) reference listed drug (RLD) and/or reference standard (RS) product by showing that they can deliver the same amount of the same...more
The Office of the Chief Scientist (OCS) in FDA's Office of the Commissioner (OC) is publishing this Funding Opportunity Announcement (FOA) to provide support for the Agency's Centers of...more
Food and Drug Administration/ Center for Devices and Radiological (CDRH) is announcing its intention to accept and consider a single source application for the award of a cooperative agreement in...more
The nasal mucosa offers an effective target for inhaled drugs that either treat localized nasal conditions or quickly deliver drugs to the systemic circulation [1–3]. While nasal spray drug...more
Dry powder inhalers (DPIs) are typically formulated as a combination of the active pharmaceutical ingredient (API) and significantly larger carrier particles [1-2]. The device is actuated via...more
Background: Although physiologically-based pharmacokinetic (PBPK) modeling is a methodology introduced in the 1940's, recent advancements in computation and an expanding body of experimental...more
Although physiologically-based pharmacokinetic (PBPK) modeling is a methodology introduced in the 1940's, recent advancements in computation and an expanding body of experimental in vivo/in...more
Generic drug products demonstrate BE to the (brand name) reference listed drug (RLD) and/or reference standard (RS) product by showing that they can deliver the same amount of the same drug to the...more
The partnership between the WCFS and FDA over the past 10 years has been very productive in supporting FDA’s public health mission by conducting studies that address knowledge gaps surrounding...more
Restaurateurs Nick Vilelle and Raj Ratwani are owners of the CAUSE gastropub, which includes a fresh menu, lively atmosphere, graffiti-inspired artwork, and a hefty beer list.