United States Food And Drug Administration (fda) - Neonatal Disorders

Relevant Publications

Determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay: Evaluation of test kit sensitivity, reference standard performance and product formulation effects on the FXIa assay.

Issue Release: 2024

Overdosage Section in US and EU Labeling.

Issue Release: 2024

Semaglutide and health risk: Development and validation of a LC-HRMS method for testing semaglutide in whole blood and application to real cases.

Issue Release: 2024

Model-based comparisons of post-treatment free IgE and FEV1 between omalizumab asthma dosing tables in the United States and European Union.

Issue Release: 2024

Performance characteristics of highly automated HSV-1 and HSV-2 IgG testing.

Issue Release: 2024

Demographic comparison of subjects in FDA approval trials in the United States to disorder specific demographics using Real World Data.

Issue Release: 2024

Evaluating the accuracy of Chat Generative Pre-trained Transformer version 4 (ChatGPT-4) responses to United States Food and Drug Administration (FDA) frequently asked questions about dental amalgam.

Issue Release: 2024

Efficacy of Fecal Microbiota (REBYOTA) in Recurrent Clostridium difficile Infections: A Systematic Review and Meta-Analysis.

Issue Release: 2024

Effects of two commonly used antidepressants amitriptyline and fluoxetine on the pharmacokinetics of abrocitinib in rats.

Issue Release: 2024

Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance.

Issue Release: 2024

Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies.

Issue Release: 2024

[Advances of monoclonal antibodies and analysis of marketed antibody drugs].

Issue Release: 2024

Sequence variation of commercially available kratom products at universal DNA barcode regions.

Issue Release: 2024

Levels of autonomy in FDA-cleared surgical robots: a systematic review.

Issue Release: 2024

Natural Weight Loss or \"Ozempic Face\": Demystifying A Social Media Phenomenon.

Issue Release: 2024

Food-Drug Effects and Pediatric Drug Development Studies Submitted to the US Food and Drug Administration, 2012-2022.

Issue Release: 2024

Loss of TROP2 and epithelial cell adhesion molecule expression is linked to grade progression in pTa but unrelated to disease outcome in pT2-4 urothelial bladder carcinomas.

Issue Release: 2024

Psychedelics in Psychiatry, the Nursing Influence, and the Future of Psychedelic Therapies.

Issue Release: 2024

US Generic Antiseizure Medication Supply Chain: Observations from Analysis of US Government Databases.

Issue Release: 2024

Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases.

Issue Release: 2024

Why is Water Purification Important for Children?

What is the Neonatal Research Network (NRN)?

How Can Communities Support Polio Eradication Efforts?

What are the Recommendations for Newborn Hearing Screening?

How are the Results Communicated?

Why are Children More Susceptible?

Why is Non-Nutritive Sucking Important?

What are the symptoms of calcium deficiency in children?

What steps can be taken to mitigate biases in pediatric care?

What are the legal requirements for security in pediatric healthcare settings?

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