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Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.
The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, [1] which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference ...
An FDA building. The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
A new rule from the Food and Drug Administration (FDA) will update what it means for food to be labeled “healthy” for the first time in 30 years, a move that aligns with current nutrition ...
PharmGKB tags each FDA or EMA label with a PGx level based on internally created guidelines: Genetic testing required: The label states or implies that some sort of gene, protein or chromosomal testing, including genetic testing, functional protein assays, cytogenetic studies, etc., should be conducted before using this drug. This requirement ...
The FDA is also working on a symbol that can be put on packages to help consumers more easily identify foods that are considered healthy and developing a plan for nutrition labeling that would go ...
US FDA warns online vendors selling unapproved weight-loss drugs. December 17, 2024 at 2:29 PM (Reuters) - The U.S. Food and Drug Administration said on Tuesday it has sent warning letters to four ...