The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
The US Food and Drug Administration (FDA) has just released its long-awaited Warning Letter to Sun Pharmaceuticals following a 483 and import alert announced earlier this year. And as the letter ...
The market has opportunities in comprehensive training for computer system validation, particularly in regulated industries. Key areas include mastering FDA regulations, agile vs. waterfall ...
Ramakrishna Sesham, Senior Manager at Astellas Pharma, develops enterprise data governance frameworks that reduce FDA submission delays, enabling faster approval of oncology therapies reaching ...
The FDA is preparing 2026 guidance on artificial intelligence in drug manufacturing and digital health technologies in clinical trials to align innovation with strict compliance requirements. Industry ...
On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to ...
TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, today announced the ...
Zydus Biologics' injectable plant in Ahmedabad received seven observations during a recent USFDA inspection, with no data ...
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