Nipro recalls bicarbonate dialysate concentrate due to contamination. Learn about potential serious injuries, fatality risks and essential steps for healthcare providers and patients for this Class I recall.
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Human Drug Compounding
Compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.FDA use of Real-World Evidence in Regulatory Decision Making
The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.Artificial Intelligence for Drug Development
FDA recognizes the increased use of AI throughout the drug development process and across a range of therapeutic areas. Learn more.Handelnine Global, LLC dba Navafresh – 716013 – 11/17/2025
Unapproved New Drugs/Adulterated/MisbrandedFDA approves 1st drug for thymidine kinase 2 deficiency, a very rare mitochondrial disease
FDA approves 1st drug for thymidine kinase 2 deficiency, a very rare mitochondrial diseaseByHeart Inc. dba BlendHouse Allerton. Allerton, IA. EIR issued 01/30/2024
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 01/30/2024
Short Title (70 char) ByHeart Inc. dba BlendHouse Allerton. Allerton, IA. EIR issued 01/30/2024
FEI Number 1921383
Firm Name ByHeart Inc. dba BlendHouse Allerton
Record Type EIR
State IA
Establishment