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http://www.fda.gov/

An agency of the United States Department of Health and Human Services, one of the United States federal executive departments that is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary products. The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. (Wikipedia)

Proper citation: U.S. Food and Drug Administration (RRID:SCR_012945) Copy   

•   Source: SciCrunch Registry

http://www.asn-online.org/khi/

Consortium that brings together the kidney community (patient advocacy groups, industry, government agencies, and professional organizations) to overcome existing challenges, including regulatory and nonregulatory barriers, and optimize the development and safety of products that impact kidney health including drugs, devices, biologics, and food products. The goals of the consortium are to: * Facilitate dialogue and research that informs regulatory processes with regard to the kidney health of patients being treated for kidney-related as well as other diseases. * Assess current medical therapies and diagnostics to identify areas in need of greater innovation and/or better defined regulatory pathways. * Develop innovative and efficient trial designs appropriate to answer the most important questions related to kidney health. * Establish expert consensus around common terminology and key definitions related to kidney health. * Develop approaches to the systematic collection of retrospective or prospective data, such as registries and/or global databases, and establishment of data standards. * Coordinate think tanks, public forums, educational exchanges, and other events to promote discussion and updates on topics in kidney health pertaining to drug, device, biologics, and food product development and evaluation. * Create transparent infrastructure and processes that facilitate collaboration and communication among the greater nephrology community and the FDA, including: * Seek input from all stakeholders (including nephrologists and other health professionals, patient groups, industry, the National Institutes of Health, the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, and other federal agencies). * Leverage previously conducted and ongoing clinical studies, research infrastructure, and databases. * Create an open and efficient mechanism for encouraging and objectively evaluating potential projects submitted to KHI. * Involve consortium members in the selection and execution of projects. * Establish systems to optimize post-market surveillance of products that affect kidney health, either intentionally or via adverse drug reactions. * Author journal articles and white papers regarding key issues, describing opportunities and challenges and proposing solutions, as well as promoting execution of these solutions.

Proper citation: Kidney Health Initiative (RRID:SCR_003869) Copy   

•   Source: SciCrunch Registry

http://www.fda.gov/ScienceResearch/BioinformaticsTools/Arraytrack/default.htm

THIS RESOURCE IS NO LONGER IN SERVICE. Documented on May 23,2023. Provides an integrated solution for managing, analyzing, and interpreting microarray gene expression data.

Proper citation: ArrayTrack (RRID:SCR_012839) Copy   

•   Source: SciCrunch Registry

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   

•   Source: SciCrunch Registry

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM382536.pdf

Urinary kidney biomarkers (KIM-1, albumin, total protein, 2-microglobulin, cystatin C, clusterin and trefoil factor-3) that are considered acceptable biomarkers for the detection of acute drug-induced nephrotoxicity in rats and can be included along with traditional clinical chemistry markers and histopathology in toxicology studies. These biomarkers may be used voluntarily as additional evidence of nephrotoxicity in nonclinical safety assessment studies to complement the standard data (BUN and sCr). In ROC analyses, some of these biomarkers showed better sensitivity and specificity than BUN and sCr relative to histopathological alterations considered to be the gold standard when tested with a limited number of nephrotoxicant and control compounds.

Proper citation: PSTC Nephrotoxicity Biomarkers (RRID:SCR_003709) Copy   

•   Source: SciCrunch Registry

http://www.fda.gov/drugs/developmentapprovalprocess/drugdevelopmenttoolsqualificationprogram/default.htm

To support Drug Development Tools development efforts, FDA established qualification programs for animal models for use under Animal Rule, biomarkers, and clinical outcome assessments. DDTs are methods, materials, or measures that have potential to facilitate drug development. Examples of DDTs may include, but are not limited to biomarker2 used for clinical trial enrichment, clinical outcome assessment used to evaluate clinical benefit, and animal model used for efficacy testing of medical countermeasures under regulations commonly referred to as Animal Rule3.

Proper citation: Drug Development Tools Qualification Programs (RRID:SCR_003714) Copy   

•   Source: SciCrunch Registry

http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm

Database of Orphan Drug Product designations. Searches may be run by entering the product name, orphan designation, and dates. Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet.

Proper citation: Search Orphan Drug Designations and Approvals (RRID:SCR_010256) Copy   

•   Source: SciCrunch Registry

http://www.accessdata.fda.gov/scripts/animaldrugsatfda/index.cfm?gb=1

THIS RESOURCE IS NO LONGER IN SERVICE. Documented on September 23,2022. Database of approved veterinary drugs run by the FDA.

Proper citation: AnimalDrugsatFDA (RRID:SCR_010257) Copy   

•   Source: SciCrunch Registry

http://www.hhs.gov/

http://www.hhs.gov/grants/

Proper citation: U.S. Department of Health and Human Services (RRID:SCR_009983) Copy   

•   Source: SciCrunch Registry

http://www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/

The National Center for Toxicological Research (NCTR), FDA's internationally recognized research center, plays a critical role in FDA's mission. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles. The NCTR is an important research component of the FDA that plays a critical role in the missions of FDA and DHHS to promote and protect public health. * NCTRin partnership with researchers from government, academia, and industrydevelops, refines, and applies current and emerging technologies to improve safety evaluations of FDA-regulated products. * NCTR fosters national and international collaborations to improve and protect public health and enhance the quality of life for the American people. Through the training of scientists from around the world, as well as FDA staff, NCTR researchers spread the principles of regulatory science globally. * NCTR conducts FDA research with the goal to develop a scientifically sound basis for regulatory decisions and reduce risks associated with FDA-regulated products. NCTR represents the FDA on key committees of the National Toxicology Program (NTP), a program that evaluates the effects of chemicals on health. Over the past 30 years, the NTP and NCTR have conducted studies on FDA-nominated compounds, providing data to support science-based regulatory decisions.

Proper citation: National Center for Toxicological Research (RRID:SCR_002943) Copy   

•   Source: SciCrunch Registry

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   

•   Source: SciCrunch Registry

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM294644.pdf

Serum / plasma biomarkers, Cardiac troponins T (cTnT) and I (cTnI), in safety assessment studies for rats, dogs, and monkeys are qualified biomarkers for the following contexts of use: # When there is previous indication of cardiac structural damage with a particular drug, cardiac troponin testing can help estimate a lowest toxic dose or a highest non-toxic dose to help choose doses for human testing. In this case, cardiac troponins may serve as a clinical chemistry correlate to the histology. For example, in a safety assessment study, lower doses without increases in cardiac troponins may be used to support a no observed effect level (NOEL) identified by histology. # When there is known cardiac structural damage with a particular pharmacologic class of a drug and histopathologic analyses do not reveal structural damage, circulating cardiac troponins may be used to support or refute the inference of low cardiotoxic potential. # When unexpected cardiac structural toxicity is found in a nonclinical study, the retroactive (reflex) examination of serum or plasma from that study for cardiac troponins can be used to help determine a no observed adverse effect level (NOAEL) or lowest observed adverse effect level (LOAEL). The results of this testing may support inclusion of cardiac troponin testing in subsequent safety assessment studies.

Proper citation: O'Brien Reagan York and Jacobsen Drug-induced Cardiotoxicity Biomarkers (RRID:SCR_003717) Copy   

•   Source: SciCrunch Registry

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM285010.pdf

Urinary kidney biomarkers, Clusterin and Renal Papillary Antigen-1 (RPA-1), that sponsors may use to determine more conservative NOAELs for estimating starting doses in the initial human clinical trial of a drug that displays nonclinical nephrotoxicity as determined by histopathology. When tested with a limited number of nephrotoxic compounds, the Receiver Operating Characteristic (ROC) analyses showed that urinary clusterin and renal papillary antigen-1 (RPA-1) have better sensitivity and specificity than BUN and creatinine for the detection of specific kidney pathologies in male rats. Clusterin and RPA-1 provide additional and complementary information to BUN, serum creatinine (sCr), and histopathology for the detection of acute drug-induced nephrotoxicity in safety assessment studies.

Proper citation: ILSI HESI Drug-induced Nephrotoxicity Biomarkers (RRID:SCR_003716) Copy   

•   Source: SciCrunch Registry

https://scicrunch.org/resolver/SCR_002250

THIS RESOURCE IS NO LONGER IN SERVICE. Documented Jul 19, 2024. Metadatabase manually curated that provides web accessible tools related to genomics, transcriptomics, proteomics and metabolomics. Used as informative directory for multi-omic data analysis.

Proper citation: OMICtools (RRID:SCR_002250) Copy   

•   Source: SciCrunch Registry

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   

•   Source: SciCrunch Registry

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

This database includes a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. This database contains content that is current as of April 1, 2013. For a daily compilation of CFR and Federal Register amendments, see the Electronic Code of Federal Regulations.

Proper citation: CFR - Code of Federal Regulations Title 21 (RRID:SCR_013090) Copy   

•   Source: SciCrunch Registry

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Database that contains information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998. Dates of Coverage: 1939-present Update frequency: Daily. Data imported from the Orange Book depends on its update frequency.

Proper citation: DrugsAtFDA (RRID:SCR_010255) Copy   

•   Source: SciCrunch Registry