Rationale for FDA’s Position on Ceftazidime Breakpoints against Stenotrophomonas Maltophilia
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Compounding when Drugs are on FDA’s Drug Shortages List
FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded drugs as an option to get the medication they need.Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials.The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug DevelopmentWhy Not Natural, Houston, Texas, is Recalling its Why Not Natural Organic Moringa – Green Superfood because of Possible Health Risk
Why Not Natural, Houston, Texas, is voluntarily recalling its Why Not Natural Organic Moringa – Green Superfood because they may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened imSterling Distributors, LLC – 03/06/2025
Sterling Distributors, LLC – 03/06/2025. Country: United States. Record Type: 483International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate Nonpareils
International Foodsource, LLC of Randolph NJ is recalling 10 oz packages of Southeastern Grocers Dark Chocolate Nonpareils, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume t
