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FDA Denies Probiotics CFU Petition

[ Price : $8.95]

FDA says it will continue to monitor research into quantifying live microbial dietary ingredients in probiotics rather than approv...

FDA Revises Drug Compounding MOU

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FDA commissioner Scott Gottlieb announces a revised memorandum of understanding to be signed with states that want to collaborate ...

PQ/CMC Meeting Scheduled for 10/19

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FDA sets a 10/19 public meeting on standardized data for electronic submission of Pharmaceutical Quality/Chemistry Manufacturing a...

FDA Enteral Device Connector Concerns

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FDA airs concerns about misconnections with enteral devices.

Iridex 510(k) for Laser Accessory Cleared

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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

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

Probiotic CFU Enforcement Discretion

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FDA issues a draft guidance saying it will exercise enforcement discretion to allow companies that produce probiotic dietary suppl...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

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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

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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

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