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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...[ Price : $8.95]
Federal Register notice: FDA requests that stakeholders notify it about their intent to participate in periodic consultation meeti...[ Price : $8.95]
FDA posts a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards.[ Price : $8.95]
FDA posts an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning t...[ Price : $8.95]
Becton Dickinson CareFusion 303 recalls its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or ...[ Price : $8.95]
Federal Register notice: FDA corrects a 9/2 Federal Register notice that announced the availability of drug post-marketing pediatr...[ Price : $8.95]
FDA releases a final guidance on Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trial...[ Price : $8.95]
FDA issues a temporary guidance entitled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public He...