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Breast Cancer Immunotherapy: A Clinical Review for the Plastic Surgeon.
Plast Reconstr Surg Glob Open
June 2024
From the Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, Md.
Background: Immunotherapy has transformed breast cancer management. However, it can be challenging to remain familiar with the adverse events, contraindications, and perioperative recommendations for each agent.
Methods: We used FDALabel to identify all Food and Drug Administration-approved immunotherapies indicated for the treatment of breast cancer.
A framework enabling LLMs into regulatory environment for transparency and trustworthiness and its application to drug labeling document.
Regul Toxicol Pharmacol
May 2024
Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA. Electronic address:
Regulatory agencies consistently deal with extensive document reviews, ranging from product submissions to both internal and external communications. Large Language Models (LLMs) like ChatGPT can be invaluable tools for these tasks, however present several challenges, particularly the proprietary information, combining customized function with specific review needs, and transparency and explainability of the model's output. Hence, a localized and customized solution is imperative.
View Article and Find Full Text PDFLight-Sensitive Injectable Prescription Drugs-2022.
Hosp Pharm
October 2023
University of Illinois at Chicago College of Pharmacy, Chicago, IL, USA.
This chart is an update to the 2014 article published in Hospital Pharmacy on injectable drugs that require protection from light. To update the chart, an online search of the FDALabel database was performed from inception through July 31, 2022 using the terms "protect" OR "light." After filtering out drugs with non-injectable routes of administration, the list of generic drug names was combined with the 2014 list and duplicates were removed.
View Article and Find Full Text PDFRisk for Postmarket Black Box Warnings in FDA-Approved Monoclonal Antibodies.
Mayo Clin Proc Innov Qual Outcomes
February 2022
Division of Allergy, Asthma, and Clinical Immunology, Mayo Clinic, Scottsdale, AZ.
Objective: To estimate the potential risk for a future postmarket black box warning (BBW) of US Food and Drug Administration (FDA)-approved monoclonal antibodies (mAbs) because of the importance for medical clinicians to understand mAb risks and benefits, including unknown future risks, especially for recently approved mAbs.
Methods: The complete dates of the study were March 16, 2020, through May 12, 2021. We searched the FDALabel database online and reviewed the scientific literature to determine current and previous FDA-approved mAbs as of March 2020.
FDALabel for drug repurposing studies and beyond.
Nat Biotechnol
December 2020
National Center for Toxicological Research, US FDA, Jefferson, AR, USA.
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