April 5, 2024
The US Food and Drug Administration (FDA) has approved the first-ever prescription app for major depressive disorder (MDD). The app, Rejoyn, was developed by Otsuka Pharmaceutical […]
April 5, 2024
What are Quality Metrics? For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data […]
April 5, 2024
For Immediate Release: April 05, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]
April 5, 2024
Image One of the U.S. Food and Drug Administration’s jobs is to carefully evaluate the scientific data on a drug to be sure that it is […]
April 5, 2024
Summary Company Announcement Date: April 05, 2024 FDA Publish Date: April 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains methanol Company […]
April 5, 2024
A group of researchers urged US regulators to revoke the approval of a test marketed for predicting risk for opioid addiction and said government health plans […]
April 5, 2024
Docket Number: FDA-2020-D-1794 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA is announcing the availability of a guidance for industry entitled “Evaluation […]
April 5, 2024
The transplant team at Massachusetts General Hospital (MGH) reports that the recipient of the first-ever transplant of a genetically edited porcine kidney into a living human […]
April 5, 2024
Quick Links This page provides quick links to key guidances to support the submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), […]
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