In Brief: Summit Technology
This article was originally published in The Gray Sheet
Summit Technology: Summary of safety and effectiveness data for Summit's SVS Apex excimer laser PMA is available through FDA's Dockets Management Branch, according to an Aug. 15 Federal Register notice. A premarket approval application for the laser's use in photorefractive keratectomy received FDA approval Oct. 20, 1995. Publication of the summary allows for submission of petitions challenging the approval. FDA has said it expects the Summit PMA, as well as Visx's PMA for its Star PRK laser to be challenged. For more information, contact Debra Lewis, head of the Center for Devices and Radiological Health's Staff College, at 301/827-3623...
You may also be interested in...
As the first emergency use authorization is granted, Pfizer and Moderna stand accused of neglecting poorer nations as wealthy countries snap up early access to COVID-19 vaccines.
The FDA has released final guidance on “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA” for the industry. The guidance brings clarity and aims at facilitating product development meetings between the FDA and the ANDA applicants for complex products.
By handing out free supplements to the clinically vulnerable, the UK government is effectively endorsing the use of vitamin D to reduce the risk and/or severity of COVID-19, although it says more research is needed.