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DoJ Changes 2 Guidance Policies: Attorneys

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Attorneys Anne Walsh and JP Ellison describe changes to two Justice Department policies on using guidance documents in enforcement...

CGMP Violations at Turkeys Gulsah Uretim Kozmetik

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FDA warns Turkeys Gulsah Uretim Kozmetik Sanayi Anonim Sirketi about CGMP violations in its production of finished drugs.

FDA Revokes 15 EUAs Granted During Covid

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Federal Register notice: FDA revokes 15 Emergency Use Authorizations on 12 decontamination systems for personal protective equipme...

Two Top CBER Vaccine Officials Leaving FDA

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Two senior CBER vaccine officials announce they are leaving FDA over the next couple of months untimely departures that signal tr...

Medication Errors Related to IND Labels Discussed

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FDA and the Reagan-Udall Foundation hold a two-day meeting on the role of investigational drug labels in medication errors.

Guide on Trial Data Sets for NASH Drugs

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FDA releases a guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic No...

Coordinated National Trial Infrastructure Needed: Gottlieb

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Former FDA commissioner Scott Gottlieb says the nation needs a coordinated national clinical trial infrastructure for use during p...

Use Risk Assessments on Trial Monitoring Decisions: FDA

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FDA revises its guidance on remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitorin...

2 New MAPPs Out

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CDER issues Manuals of Policies and Procedures on scientific interest groups and data standards.

MiRus Lumbar Interbody Device Cleared

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FDA clears a MiRus 510(k) for its IO Expandable Lumbar Interbody device for use in posterior and transforaminal fusion procedures.