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Iridex 510(k) for Laser Accessory Cleared

[ Price : $8.95]

FDA clears an Iridex 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used ...

FDA Approves Tevas Cassipa for Opioid Dependence

[ Price : $8.95]

FDA approves Tevas Cassipa, a stronger dose of buprenorphine and naloxone sublingual film for maintenance treatment of opioid depe...

Probiotic CFU Enforcement Discretion

[ Price : $8.95]

FDA issues a draft guidance saying it will exercise enforcement discretion to allow companies that produce probiotic dietary suppl...

Violative Drugs at Avella Specialty Pharmacy

[ Price : $8.95]

FDA says the Avella Specialty Pharmacy acquisition Advanced Pharma produced compounded drugs that violated the Federal Food, Drug,...

Expand 510(k) Exemption to Muscle Sensors: Petition

[ Price : $8.95]

An Ohio State University medical school professor asks FDA to expand 510(k) exemption status to include optical sensor devices use...

Nonallergic Rhinitis Drug Development Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Nonallergic Rhinitis: Developing Drug Products for Treatment.

Guide on Allergic Rhinitis Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Allergic Rhinitis: Developing Drug Products for Treatment.

Refuse to File Policy MAPP

[ Price : $8.95]

CDER issues a MAPP clarifying the refuse-to-file process for specific types of drug applications.

Intuitive Surgical 510(k) for Robotic Lung Biopsy

[ Price : $8.95]

Intuitive Surgical files a 510(k) for the companys new flexible robotic-assisted, catheter-based platform for lung airway biopsies...

FDA Making Progress in Generic and Biosimilar Access: Abram

[ Price : $8.95]

FDA deputy commissioner Anna Abram says the agency is making significant progress on action plans to improve drug competition and ...