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Alcon Research Ltd.

Division of Novartis AG
www.alcon.com

Latest From Alcon Research Ltd.

US Approvals Analysis: July A Good Month For PMAs; 510(k)s Down In 2016

A look at Medtech Insight's Approval Tracker data shows that last month was a relatively active one for US FDA approvals of novel devices via the PMA, panel-track supplement and de novo routes. But 510(k) clearance totals are down so far in 2016 compared to recent years.

Research & Development Regulation

New Drugs Show How FDA Incentives Look Beyond Innovation

FDA’s first-in-class drug approvals show a healthy rate of innovation, but the 2014 novel agent cohort is more notable for the high level of clinically meaningful advances in therapy for serious diseases. Two-thirds of CDER’s novel approvals qualified for at least one expedited development and review program; only half of those products represent a new pharmacologic class.

BioPharmaceutical Regulation

New Drugs Show How FDA Incentives Look Beyond Innovation

FDA’s first-in-class drug approvals show a healthy rate of innovation, but the 2014 novel agent cohort is more notable for the high level of clinically meaningful advances in therapy for serious diseases. Two-thirds of CDER’s novel approvals qualified for at least one expedited development and review program; only half of those products represent a new pharmacologic class.

BioPharmaceutical Approvals

FDA Challenges “Game Changing” Superiority Claim For ParaPRO’s Natroba

CDER’s Office of Prescription Drug Promotion takes issue with a superiority claim for the Rx head lice treatment spinosad because the sponsor has not demonstrated a “significant advantage” over existing prescription products.

BioPharmaceutical United States
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