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Gestational diabetes is a condition in which a woman without diabetes develops high blood sugar levels during pregnancy. [ 4 ] Type 2 diabetes mellitus and prediabetes are associated with changes in levels of metabolic markers, these markers could serve as potential prognostic or therapeutic targets for patients with prediabetes or Type 2 ...
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
The 2022 American Diabetes Association (ADA) standards of medical care in diabetes include GLP-1 agonists or SGLT2 inhibitors as a first-line pharmacological therapy for type 2 diabetes in patients who have or are at high risk for atherosclerotic cardiovascular disease or heart failure. They are also a first-line treatment for people with both ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues [1] to examine normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. [2]
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
The FDA and other regulatory agencies will often accept evidence from clinical trials that show a direct clinical benefit to surrogate markers. [3] Surrogate endpoints can be obtained from different modalities, such as, behavioural or cognitive scores, or biomarkers from Electroencephalography , MRI, PET, or biochemical biomarkers.
Drugs used in diabetes treat types of diabetes mellitus by decreasing glucose levels in the blood. With the exception of insulin , most GLP-1 receptor agonists ( liraglutide , exenatide , and others), and pramlintide , all diabetes medications are administered orally and are thus called oral hypoglycemic agents or oral antihyperglycemic agents.