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Gormley Adds Oncology Endpoint Role at FDA

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CDER Division of Hematologic Malignancies 2 division director Nicole Gormley is named acting associate director for oncology endpo...

AI Ultrasound Gains De Novo Backing for Nerve Block

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FDA grants Intelligent Ultrasound a de novo marketing authorization for its artificial intelligence ScanNav Anatomy Peripheral Ner...

Info Collection on Right to Try

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Federal Register notice: FDA sends to OMB a proposed information collection entitled Annual Summary Reporting Requirements Under t...

Catalent Brussels Plant Inspected Again

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For the second time in a year, FDA inspects contract manufacturer Catalents Brussels, Belgium, manufacturing facility.

Comments Extended on Non-Rx Drug Proposed Rule

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Federal Register notice: FDA extends the comment period for a 6/28 proposed rule entitled Nonprescription Drug Product With an Add...

Draft Guide on Breakthrough Devices Program

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Breakthrough Devices Program Guidanc...

Guide on Drug Trial Multi-Endpoints

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Federal Register notice: FDA makes available a final guidance entitled Multiple Endpoints in Clinical Trials.

FDA Extends Compounded Drug Enforcement Discretion

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Federal Register notice: FDA extends the period before it intends to begin enforcing a statutory 5% limit on distribution of compo...

FDA Continues Paired Meetings on Trial Designs

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Federal Register notice: FDA announces the continuation of its paired meeting program that aims to advance the use of complex inno...

Guide on Gene Therapies for Neurodegenerative Diseases

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FDA posts a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases.