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Finalize Race, Ethnicity Data Guidance: DFA

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Doctors for America calls on FDA to finalize a guidance on collecting race and ethnicity data in clinical trials and clinical stud...

Multiple Violations at Indonesias P.T. Sankei

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FDA warns Banten, Indonesia-based P.T. Sankei Medical Industries about Quality System and Medical Device Reporting violations in t...

Aquestives Diazepam Buccal Film Approved

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FDA approves an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereoty...

FDA Clears Hybrid Sacroiliac Joint Implant

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FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion cons...

Guide on Public Health Emergency IVDs

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Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices ...

Test Enforcement Policies During Emergency Guide

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Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Se...

Update Informed Consent Guidance: AdvaMed

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AdvaMed calls for updates to FDA and HHS informed consent guidances.

High-Concentration Humira Biosimilar OKd

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FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable b...

Multiple Pinnacle BioLabs Violations Seen

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FDA warns Nashville, TN-based Pinnacle BioLabs that it is marketing and distributing a diagnostic test for an unapproved indicatio...

QS, MDR Violations at Future Diagnostics

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FDA warns Gelderland, Netherlands-based Future Diagnostics Solutions about Quality System and Medical Device Reporting violations ...