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CGMP Violations, Deviations at Mayons Pharmaceuticals

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FDA warns Indias Mayons Pharmaceuticals about CGMP issues in its manufacturing of finished drugs and APIs.

FDA, CDC Have Lost Bill Gates Trust

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Bill Gates says he no longer has trust in FDA and CDC as independent regulators because of the way they have responded to Trump ad...

FDA Turns Down Mallinckrodt NDA for Terlipressin

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FDA sends Mallinckrodt a complete response letter on its NDA for terlipressin and its use in treating adults with hepatorenal synd...

Stakeholder Notification for GDUFA Reauthorization Participation

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Federal Register notice: FDA requests that stakeholders notify it about their intent to participate in periodic consultation meeti...

Guidance on Device Consensus Standards

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FDA posts a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards.

Update on Software as a Medical Device Pilot

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FDA posts an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning t...

BD Alaris Pump Recall on Hardware Issues

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Becton Dickinson CareFusion 303 recalls its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or ...

Notice Correction on Pediatric Drug Safety Reviews

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Federal Register notice: FDA corrects a 9/2 Federal Register notice that announced the availability of drug post-marketing pediatr...

Guidance on Assessing Covid Symptoms in Clinical Trials

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FDA releases a final guidance on Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trial...

De Novo Authorization for Glycemic Controller

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FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controlle...