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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...

Guidance on Resuming Normal Drug/Biologic Manufacturing

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FDA issues a temporary guidance entitled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public He...

Regulatory Review Period for Dyaxs Takhzyro

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dyax Corp.s Takhzyro, indic...

Covid-19 Vaccine Emergency Use Guide Soon: FDA

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FDA says it will soon issue a guidance for sponsors to request an Emergency Use Authorization for their vaccines, including recomm...