The U.S. Food and Drug Administration has updated its infant formula compliance program for investigators, laboratory analysts and compliance officers. The compliance program is designed to ...
In response to the infant formula supply crisis in 2022 and the deadly infections that led to it, the FDA has updated its infant formula compliance program. An outbreak of Cronobacter infections in ...
ORLANDO, Fla. — The FDA is initiating a program to improve retailer compliance in order to fight youth vaping, focusing on vape shops, convenience stores, and gas stations nationwide. The initiative ...
George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...
Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...
FDA is seeking additional authorities and funding in its fiscal 2025 budget request to enhance its oversight – and by extension safety enforcement – of new food ingredients, additives and contact ...
From a global regulatory perspective, Cytokinetics is expanding its footprint rapidly. The drug received approval in China on ...
Quality issues are still the number one reason for drug shortages, and in an effort to address this, the U.S. Food and Drug Administration is debuting a quality management maturity (QMM) program ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
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