Background: Obtaining human pregnancy data to inform product labeling is important for drug and biological products.
Methods: Collection and analyses of safety data on their use during pregnancy is usually performed after approval.
Results: The Centers for Disease Control National Birth Defects Prevention Study has provided important data on the relationship between drug use in pregnancy and birth defects.
Conclusion: The Pregnancy and Lactation Labeling Rule will set new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy; the National Birth Defects Prevention Study, along with other data sources, will be critical for providing safety data to inform product labeling.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/bdra.23403 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Comparative study of the oral hygiene status of users of mefakia (traditional tooth cleaning method) and modern toothbrushes among patients at the Holy Bethel Dental Clinic in Addis Ababa, Ethiopia.
BDJ Open
December 2024
School of Public Health, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.
Background: Mefakia is a well-known traditional chewing wood used in Ethiopia to cleanse the mouth. Although mefakia is used in parallel with modern toothbrushes to improve oral hygiene, there is a gap in the literature regarding its comparative performance in removing plaque and maintaining good oral hygiene.
Objective: This study aimed to evaluate and compare the oral hygiene status of patients using mefakia and modern toothbrushes at the Holy Bethel Dental Clinic in Addis Ababa, Ethiopia.
Swab Testing to Optimize Pneumonia treatment with empiric Vancomycin (STOP-Vanc): study protocol for a randomized controlled trial.
Trials
December 2024
Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Background: Vancomycin, an antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA), is frequently included in empiric treatment for community-acquired pneumonia (CAP) despite the fact that MRSA is rarely implicated in CAP. Conducting polymerase chain reaction (PCR) testing on nasal swabs to identify the presence of MRSA colonization has been proposed as an antimicrobial stewardship intervention to reduce the use of vancomycin. Observational studies have shown reductions in vancomycin use after implementation of MRSA colonization testing, and this approach has been adopted by CAP guidelines.
View Article and Find Full Text PDFAssociation between antinuclear antibodies status and preterm birth in Japanese pregnant women: a prospective cohort study from Adjunct Study of the Japan Environment and Children's Study.
BMC Pregnancy Childbirth
December 2024
Kumamoto University Regional Centre, The Japan Environment and Children's Study (JECS), 718, Medical Research Building, 1-1-1 Honjo, Chuo-ku, Kumamoto, Kumamoto, 860-8556, Japan.
Background: Antinuclear antibodies (ANA) are important biomarkers for the diagnosis of autoimmune diseases; however, the general population also tests positive at a low frequency, especially in women. Although the effects of various autoimmune diseases on pregnancy outcomes have been studied, the association of ANA with pregnancy outcomes in healthy individuals is unclear. Preterm birth (PTB), a major cause of neonatal death or long-term health problems, is a complex condition with a multifactorial etiology, and the underlying mechanism remains unclear.
View Article and Find Full Text PDFA cross-sectional study assessing customers' perception, satisfaction, and attitude toward e-pharmacy services in Saudi Arabia.
BMC Health Serv Res
December 2024
Clinical Pharmacy Department, College of Pharmacy, King Khalid University, Abha, Saudi Arabia.
Background: Electronic pharmacy (e-pharmacy) services are growing rapidly, offering increased accessibility, privacy, and value. Understanding e-pharmacy customer satisfaction, attitudes, and perceptions in Saudi Arabia is crucial for improving the services and enhancing health outcomes. This study aims to examine customers' perceptions, preferences, satisfaction, and experiences with electronic pharmacy services, including community pharmacy e-commerce.
View Article and Find Full Text PDFUnveiling insights from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) portal.
Sci Data
December 2024
Unit of Biostatistics, Epidemiology, and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, via Loredan 18, Padova, 35131, Italy.
This study presents a method for automating the retrieval of key identifies and links to toxicological data from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) database using web scraping techniques. Although the method primarily serves as an automated indexing tool, facilitating organization and access to relevant reports, monographs, and specifications, it significantly enhances the efficiency of navigating the extensive JECFA database. Researchers can then perform more targeted and efficient searches, although additional manual steps are required to extract and structure the detailed toxicological data.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!