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 ...
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 ...
George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...
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 ...
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 ...
Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...
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