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| http://dx.doi.org/10.1001/jamainternmed.2022.4226 | DOI Listing |
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Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA-GMO-NL-2015-126). The applicant conducted a 90-day feeding study on GM soybean MON 87705 and provided a proposal for post-market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90-day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment-related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days.
View Article and Find Full Text PDFAddressing Drug-Drug Interaction Knowledge Gaps at the Time of Approval: An Analysis of FDA Postmarketing Requirements and Commitments from 2009 to 2023.
J Clin Pharmacol
October 2024
Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.
It has become increasingly common for patients to rely on the use of multiple prescription medications. The management of polypharmacy requires careful consideration for how drugs are metabolized and their potential for interaction with other drugs. Drug-drug interaction (DDI) assessments are typically performed in a stepwise manner during drug development, though knowledge gaps can exist at the time of approval.
View Article and Find Full Text PDFComparative Analysis of Post-Authorization Measures for Advanced Medicinal Products Authorized in the European Union and in the United States of America Between 2009 and 2023.
Clin Pharmacol Ther
January 2025
Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal.
In the current landscape, regulatory agencies face the challenge of reconciling timely authorizations for novel medicines addressing life-threatening conditions with thorough evaluations of their benefits and risks. This challenge is pronounced with advanced therapy medicinal products (ATMPs), where expedited approval mechanisms and orphan drug designations are often applied, making post-authorization measures a crucial mechanism to address uncertainties. We compared post-authorization measures imposed by the U.
View Article and Find Full Text PDFComparison of Costs, Re-Intervention Rates, and Length of Hospital Stay for Three Uterus Sparing Interventions for Uterine Fibroids: A 2-Year Retrospective Claims Analysis.
Clinicoecon Outcomes Res
July 2024
Department of Urology, Hoag Hospital, Newport Beach, CA, USA.
Article Synopsis
- The study aimed to evaluate the two-year post-operative outcomes and healthcare costs of three uterus-sparing procedures for treating uterine fibroids in women who wish to maintain their uterus: LAP-RFA, myomectomy, and UAE.
- A total of 54 women were randomly assigned to undergo one of the procedures, and their results were compared to a larger group of women from insurance claims data.
- The findings revealed that LAP-RFA had the lowest costs and shortest hospital stays, while UAE had the highest costs and re-intervention rates, indicating that LAP-RFA may be the most cost-effective and efficient option among the three treatments for fibroids.
Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study.
Heart Rhythm
June 2024
Cleveland Clinic Heart, Thoracic, and Vascular Institute, Cleveland, Ohio.
Background: Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations.
Objective: We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients.
Methods: Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead.
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