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Data Don't Support Breakthrough for 510(k)s: Attorney

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Attorney and data scientist Bradley Thompson says FDA data support the value of a breakthrough device designation for de novo subm...

FDA Working to Cut Ethylene Oxide Emissions

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CDRH director Jeffrey Shuren describes Center efforts to help sterilization facilities to reduce ethylene oxide emissions into the...

Juvderm Volux XC Approved for Jawline Shaping

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FDA approves Allergan Aesthetics Juvderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to s...

E-submission Guide for Expedited Safety Reports

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Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission of Expedited Safety Reports From IND-...

FDA Approves Cimerli as Generic Lucentis

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FDA approves Coherus Cimerli as an interchangeable generic version of Genentechs Lucentis for all five label indications.

Looking at the FDA/Industry Revolving Door

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A Grid news report uses Linkedin data to estimate how many former FDAers are now working in regulated companies and discusses the ...

Alnylam Pharmaceuticals Plans NDA for Patisiran

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Alnylam Pharmaceuticals plans to file an NDA submission late this year for patisiran, indicated for treating transthyretin-mediate...

Panel To Review Amylyx ALS Drug

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Federal Register notice: FDA announces a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting that will revi...

Glaukos 510(k) Cleared for Intraocular Pressure

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FDA clears a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce...

False Claims Liability for Medical Device Off-Label Use

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Attorney Keeley McCarty says a recent government suit against Promothesus Group demonstrates the government is willing to use the ...