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Public Meeting on GDUFA Goals

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Federal Register notice: FDA announces a virtual public meeting entitled Generic Drug User Fee Amendments (GDUFA) of 2017.

FDA Covid-19 Guidances Available

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Federal Register notice: FDA makes available guidance documents related to the Covid19 public health emergency.

Curativa Bay Warning Letter on Covid Spray

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FDA sends Curativa Bay (Clearwater, FL) a Warning Letter after reviewing the companys Web site and citing its Advanced Hypochlorou...

Chiasma NDA Approved for Acromegaly

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FDA approves a Chiasma NDA for Mycapssa (octreotide) capsules for long-term maintenance treatment in certain acromegaly patients.

Guide on Device Inspection Process

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FDA posts a final guidance entitled Review and Update of Device Establishment Inspection Processes and Standards.

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, J...

Colored Contact Lenses Recalled

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Chengdu Ai Qin E-commerce Co. recalls its colored contact lenses after FDA notified the firm that they were distributed without ag...

GDUFA 3 Reauthorization Public Meeting Set

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FDA sets a 7/21 virtual public meeting to hear comments on the GDUFA 3 reauthorization.

Adulterated, Misbranded Animal Drugs at Rapid Equine

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FDA warns Rapid Equine Solutions that it is providing adulterated and misbranded compounded animal drugs.

Robotic Exoskeleton Cleared for Brain Injury

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FDA clears a Ekso Bionics 501(k) for the EksoNR robotic exoskeleton for use with patients with acquired brain injury.