By Bahram Hassanpourfard, Epidemiologist
The FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for paediatric patients with congenital pulmonary valve disease, which it describes as the first heart valve designed to grow with children1. For device makers and paediatric cardiac teams, the interest lies in the design principle: a valve built to adjust in size with the patient addresses a limitation that fixed-size implants cannot. The announcement, as summarised, gives no detail on the supporting evidence or availability.
The agency also published material on its drug centre’s Center for Clinical Trial Innovation, which aims to enable and amplify existing and future clinical trial innovation through enhanced communication and collaboration2. It also posted material on the Prescription Drug User Fee Act, the 1992 law under which it collects fees from makers of certain drugs and biological products, fees it credits with helping to expedite approvals3. Neither item, as described, announces a specific new policy or decision.
References: 1. FDA · 2. FDA · 3. FDA
Source: Life Sciences Hub – lifesciences.apotekanalytics.com
