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http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm
Database that contains drug products approved on the basis of safety and effectiveness by the Food and Drug Administration.
Proper citation: Approved Drug Products with Therapeutic Equivalence Evaluations (RRID:SCR_013727) Copy
http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/
The FDA''s national strategy for transforming the way FDA-regulated products--human drugs, biological products, medical devices, veterinary drugs, foods, and cosmetics--are developed, evaluated, manufactured, and used. Specific key areas of focus identified by FDA experts and the public: * Developing better evaluation tools like biomarkers and new assays * Streamlining clinical trials by modernizing the clinical trial sciences to make trials safe and efficient * Harnessing bioinformatics (e.g., moving from a paper-based to electronic environment for exchanging information and overseeing the safety of FDA-regulated products) * Moving manufacturing into the 21st Century, using tools such as process analytic technology and nanotechnology * Developing products to address urgent public health needs, including, improved antimicrobial testing, new animal models to test bioterrorism countermeasures and vaccine testing * Focusing on at-risk populations, such as pediatrics
Proper citation: Critical Path Initiative (RRID:SCR_012967) Copy
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM380961.pdf
An electronically administered patient-reported outcome (PRO) measure that is a qualified measure of symptoms of acute bacterial exacerbation of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), for use in phase 2 trials. Refer to the proposed context of use, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM399682.pdf. Its intent to quantify frequency, severity, and duration of acute exacerbations in clinical trials of COPD including those with chronic bronchitis. It is designed as an electronic diary made up of fourteen items to be completed by the patient each evening just prior to bedtime. (An item-reduction statistical analysis narrowed the questions from 23 to 14.) For more information see, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM386248.pdf
Proper citation: Exacerbations of Chronic Pulmonary Disease Tool (RRID:SCR_003718) Copy
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