Examples of HIV/AIDS clinical trials underway include studies of new HIV medicines, studies of vaccines to prevent or treat HIV, and studies of medicines to treat infections related to HIV. Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. Visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS). The EMA and the FDA had high concordance (91–98%) in decisions on marketing approvals. FDA Clinical Trials Search. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. For more information, see How to Search. About 930 clinical trials conducted at site, including 273 Phase I-II early phase trials. Treatment of fungal infection of the toenails due to two common forms of fungi, Treatment of Lysosomal Acid Lipase (LAL) deficiency, Prevention of coronary artery blood clot formation in patients undergoing PCI, Treatment  of adult patients with moderately to severely active rheumatoid arthritis (RA), Treatment of a specific form of advanced breast cancer, For the treatment of plexiform neurofibroma. Data is available Treatment of acute migraine with or without aura, in adults, Reducing elevated intraocular pressure, when the pressure inside the eye is too high, Treatment of certain types of solid tumors, Treatment of women with certain type of advanced ovarian cancer. The Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their physician. The Snapshots program began in 2015 and reflects drugs approved after that time. At the end of each consumer section of the Snapshot, there is a shaded bar with the words “MORE INFO”. From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA: Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA. Clinical Trial Resources For more information about research and clinical trials, you can visit the following government and private sites: ClinicalTrials.gov: This site maintained by the National Library of Medicine provides extensive clinical trials information including a database of active clinical trials … Provides leadership, oversight, and guidance related to biomedical and behavioral research conducted or supported by the U.S. Department of Health and Human Services (HHS); develops educational programs and materials; and supports the Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues related to protecting human subjects in research. Snapshots are published only for approved New Molecular Entities (NMEs) and original biologics. Clinical Database Validation Disambiguation: Clinical database validation is making sure that clinical databases perform the functions required for 21 CFR 11 and other regulations. Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. FDA Perspective on International Clinical Trials Kassa Ayalew, M.D., M.P.H. Learn more on the C3iHC Blog. Treatment of Mucopolysaccharidosis VII (MPS, VII, Sly syndrome), For the treatment of diffuse large B-cell lymphoma (DLBCL). segesterone acetate and ethinyl estradiol vaginal system, Treatment of acute lymphoblastic leukemia (ALL). Drug Trials … Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials… Clinical Trials and Human Subject Protection, Recalls, Market Withdrawals and Safety Alerts, Clinical Trials and Human Subject Protection, Regulations: Good Clinical Practice and Clinical Trials, Clinical Investigations Compliance & Enforcement, FDA's Role: ClinicalTrials.gov Information, Good Clinical Practice Educational Materials, Guidance Documents (Including Information Sheets) and Notices, Replies to Inquiries to FDA on Good Clinical Practice, Reporting Complaints Related to FDA-Regulated Clinical Trials, Websites with Information About Clinical Trials, FDA’s Office of Minority Health and Health Equity, FDA's Office of Orphan Products Development, HHS Office for Human Research Protections. Search Tips and Examples. Lowering the blood levels of phenylalanine in adults with phenylketonuria (PKU), Treat high levels of parathyroid hormone (PTH), Treatment of adults with metastatic bile duct cancer (cholangiocarcinoma), Treatment of a type of constipation called chronic idiopathic constipation (CIC), Treatment of adults with diffuse large B-cell lymphoma, Treatment of metastatic squamous non-small cell lung cancer, Treatment of  adults with mycosis fungoides or Sézary syndrome, Treatment of certain patients with high cholesterol, Reversal of the anticoagulant effects of Pradaxa during emergency situations or when there is a need to reverse its blood-thinning effects, ​Treatment of lung tuberculosis in limited population, Prevention of cytomegalovirus (CMV) infection and disease in adults. Treatment of patients 12 years of age and older with the most common gene mutation that causes cystic fibrosi. The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in clinical trials that supported the FDA approval of new drugs. Specific identifier numbers will be added to all clinical trials which will then link to FDA communications on those specific trials. Prevent ion or reduction of bleeding episodes in adults and children with hemophilia A. Conclusions regarding these differences cannot always be made. The HHS Office of Inspector General conducts short-term management and program evaluations that focus on issues of concern to the Department, the Congress, and the public, including such topics as human subject protection and clinical trial oversight. Use AND (in uppercase) to search for multiple terms. Drug Approvals and Databases, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, CDER Conversations: Drug Trials Snapshots, FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots, CDER’s New Molecular Entities and New Therapeutic Biological Products, Inside Clinical Trials: Testing Medical Products in People, The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective. During ongoing clinical trials to provide real-time assessment of the investigator’s conduct of the trial and protection of human subjects; At the request of an FDA review division; and Related to certain classes of investigational products that FDA has identified as products of special interest in its current work plan (i.e., targeted inspections based on current public health concerns). Real-time data power Data access and analytics for coding, safety management, and insight-based decisions. Treatment of moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin, For the treatment of X-linked hypophosphatemia, Treatment of chronic Hepatitis C genotype 3 infection, Treatment of serious bacterial skin infections. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. Treatment of adults with newly-diagnosed acute myeloid leukemia (AML). FDA's roles in the Critical Path Initiative include identifying the scientific hurdles hindering medical product development, and serving as catalyst in bringing together stakeholders who are interested in combining their efforts to create new tools for medical product development. atoltivimab, maftivimab, and odesivimab-ebgn, ​Treatment of Zaire ebolavirus (Ebola virus) infection. MedlinePlus will direct you to information to help answer health questions. NMEs and original biologics are medications made of new molecular structures that have not been approved by the FDA before. Provides general information about clinical trials and links to additional information about trials sponsored by the National Institutes of Health. The Website provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. Use our tools on your road to profit in the stock market. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Assists and encourages the identification, development, and availability of safe and effective products for people with rare diseases and disorders. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. 臨床試験は、医薬品、医療機器等の有効性や安全性の評価を目的に行われる試験です。臨床試験のうち、医薬品、医療機器等の承認申請に使用することを目的とした臨床試験が治験であり、それ以外の臨床試験が非治験です。 Treatment of bile acid synthesis disorders due to single enzyme defects, Treatment of peroxisomal disorders, including Zellweger spectrum disorders, Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma), Treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL). For the detection of estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer. This includes wearable devices intended for medical use, as well as testing other medical devices using wearable technology. The FDA-sponsored Clinical Trial Transformation Initiative has published recommendations for conducting decentralized clinical trials through telemedicine and mobile healthcare providers6. Comments and questions can be sent to: Snapshots@fda.hhs.gov. Treatment of the flu (influenza) in people 12 years of age and older, Treatment of acute myeloid leukemia (AML) with a FLT3 mutation, Treatment of patients with hereditary orotic aciduria, Treatment of certain types of advances tissue sarcoma, Maintenance treatment of adults with a lung disease called COPD, Treatment of adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, Treatment of adults who have a complicated urinary tract infection, Treatment of chronic Hepatis C genotypes 1 or 4 infection, Treatment of relapsing forms of multiple sclerosis (MS), To treat rare conditions related to premature aging, Reduction of heart attacks and stroke in high-risk patients, Lowering uric acid levels in the blood of adult patients with gout. Treatment of chorea in patients with Huntington’s disease. The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. ​Treatment of chronic idiopathic constipation (CIC) in adults. For the treatment of adults with acute hepatic porphyria (AHP).​. Postmarket requirement and commitment studies and clinical trials occur after a drug or biological product has been approved by FDA. Safety, metabolism and excretion of the drug are also emphasized. Treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. Promotes and protects the health of diverse populations through research and communication of science that addresses health disparities. Wiley database on Gene Therapy Trials WorldwideThe Journal of Gene Medicine clinical trial site presenting charts and tables showing the number of approved, ongoing or completed clinical trials worldwide. Where can I send comments or questions about snapshots? 12 days ago. The second joint symposium was held in London in February 2020, covering international collaboration, sponsor oversight, electronic source documents, protocol deviations and data quality in novel clinical trial designs. 's-Graveland: n.a. The database is updated daily with new clinical trials. The clinical trial data collection at Pharma Intelligence includes clinical trial data sets, clinical research information, data from the FDA clinical trial database, and much more information related to drug trials… Treatment of  melanoma (a type of skin cancer)  when used with another drug binimetinib, Reversal of the effects of certain neuromuscular blocking agents. Improvement of blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise. How FDA will respond at NDA approval time regarding “weakened” studies remains to be seen. Click the “MORE INFO” bar for more technical and detailed content including data. Treatment of HIV infection in patients with limited treatment options. <臨床試験情報>ClinicalTrials.gov / IFPMA Clinical Trials Portal / PDQ Cancer Clinical Trials Registry <有害事象情報>FAERS(FDA Adverse Event Reporting System) / JAPIC AERS 参考情報 組織・団体 Mots / Words Abr. You can check out information on the LSD Trials and what stage they're at. This section is for anyone interested in additional information. This paper is an excellent outcome from our collaboration with the FDA, which will be useful to our stakeholders undertaking global clinical trials. Of these, 85,455 (49.6% Immunic, Inc. IMUX. Prevention of venous thromboembolism (VTE), bictegravir/emtricitabine/tenofovir alafenamide. The FDA guidance on IND and BA/BE reporting summarizes the FDA’s requirements and thinking on SAE reporting in clinical trials. Preformulated MEDLINE searches are included in MedlinePlus and give easy access to the medical research literature. Through Drug Trials Snapshots, FDA is addressing concerns raised by advocacy groups and the public, including important issues such as tracking information about how many women and minorities participate in drug trials. Legally, FDA has the authority to accept foreign data as … Treatment of  adults with B-cell acute lymphoblastic leukemia (ALL). The FDA requires a multi-phase clinical trials process to be completed before deciding if the medicine under investigation is safe and effective for a broader patient population. 2 Note: Standardized drug names automatically assigned by the National Library of Medicine based on drug names provided by the Responsible Party. The FDA usually requires a phase III clinical trial before approving a new medication. Treatment of seizures in two rare and severe forms of epilepsy. dut 's-Gravenhage: n.a. Treatment of adults with acute myeloid leukemia (AML) that has a mutation in a gene called FLT3, in combination with chemotherapy, Treatment of adults with advanced systemic mastocytosis (SM), insulin degludec and insulin aspart injection, Improves blood sugar control in adults with diabetes mellitus (DM), Prevention of stroke in patients with atrial fibrillation, Increasing pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria, For the treatment of certain types of acne vulgaris in patients 9 years and older, SILIQ is used for treatment of moderate to severe plaque psoriasis in adults, Treatment of serious bacterial skin infections known as acute bacterial skin and skin structure infections, Treatment of moderate to severe plaque psoriasis. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, Improvement of blood sugar control in adults with diabetes mellitus (DM) type 2 when used in addition to diet and exercise, Treatment of traveler's diarrhea in adults, Preventive treatment of migraine in adults, For the topical treatment of acne vulgaris in patients 9 years of age and older, Prevention of the nausea and vomiting that happens right away or later in adults receiving certain anticancer medicines (chemotherapy), Treatment of metastatic non-small cell lung cancer. The clinical trial data collection at Pharma Intelligence includes clinical trial data sets, clinical research information, data from the FDA clinical trial database, and much more information related to drug trials. It noted initially, similar to FDA above, that changes The .gov means it’s official.Federal government websites often end in .gov or .mil. Treatment of prostate cancer that has not spread to other parts of the body (non-metastatic), Treatment of mild to moderate atopic dermatitis in patients 2 age years of age and older, ​For the treatment of osteoporosis in women after menopause, ​For the treatment of spinal muscular atrophy (SMA), Detection of fallopian tubes patency (openness) in women with infertility, Treatment of particular type of Duchenne muscular dystrophy. Scott Gottlieb announced the FDA’s commitment to greater transparency in the drug approval process and greater access to useable information on those approvals at a forum on transparency at the FDA … If the FDA gives the green light, the investigational drug will then enter three phases of clinical trials: Phase 1: About 20 to 80 healthy volunteers to establish a drug's safety and profile, and takes about 1 year. The answer is: quite possibly. Tap into Pharma Intelligence for the latest in clinical studies and clinical trials data. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. An official website of the United States government, : dut 's-Gravenmoer: n.a. Treatment of a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced (metastatic). Volunteer to support the development of new treatments. Evaluation and proof of cosmetic and skincare products performances and properties, acting as the best marketing tool for the success and respect of the brand. Initial lab-based results and new data from 1,500 Israel-based Corona patients have been extremely promising and clinical studies are scheduled to … EORTC Investigator's Area This section gives access to the clinical trials applications designed for the investigators. MedlinePlus brings together, by health topic, authoritative information from NLM, the National Institutes of Health (NIH), other government, non-profit and other health-related organizations. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial. At the beginning and at the end of each Snapshot, there is a link to the drug’s Prescribing Information (formerly known as the Package Insert). Comprehensive site containing information about pediatric drug development activities. Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent. Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies’ conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application. Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. Treatment of partial-onset seizures in adult patients, treatment of impetigo due to certain bacteria, complicated intra-abdominal infections caused by bacteria in patients 18 years and older, Treatment of diarrhea in adult patients with carcinoid syndrome. Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older. For more information, please read: "Report to Congress: Reports on Postmarketing Studies [FDAMA 130]" and the Guidance for Industry (PDF - 456KB). No. Treatment of complicated intra-abdominal infection (abbreviated as cIAI), Treatment of complicated urinary tract infection (abbreviated as cUTI), Treatment of adults with certain gastrointestinal stromal tumors, For the treatment of urothelial carcinoma (a type of bladder and urinary tract cancer), Treatment of post-operative nausea and vomiting. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA FDA Clinical Trials Search. Treatment of adults with mantle cell lymphoma. The .gov means it’s official.Federal government websites often end in .gov or .mil. FDA Pilot Project to Develop a Clinical Database to Examine Safety in Trials Using CAR T-cells Maura O’Leary, MD Team Leader Center for Biologics Evaluation and Research Office of Tissues and Advanced Therapies Clinical Prevention of malaria relapse caused by the parasite, Treatment of progressive, differentiated thyroid cancer (DTC) that can no longer be treated with radioactive iodine, Treatment of advanced skin cancer (squamous cell carcinoma), Treatment of specific type of lung cancer. Clinical Trials Center for Skincare and Cosmetics in Thailand. For the treatment of symptoms associated with opioid withdrawal during abrupt opioid discontinuation. Prevention of attacks of hereditary angioedema (HAE) in patients 12 years and older. dut 's-Heerenberg: n.a. The EORTC Clinical Trials Database contains information about EORTC clinical trials and clinical trials from other organisations with EORTC participation. Find Studies The Find Studies section of this site describes the options for finding studies on ClinicalTrials.gov, how to use those options to find the studies you are looking for, and how to read study records. Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided Snapshots aim to present differences in how well the drug works and side effects among different demographic groups. Are individual Snapshots updated? Safety data from ongoing clinical trials influence the clinical care of patients enrolled in those and other trials of a given drug; if the drug is already on the market, these data may affect its clinical use. Consequences from Data Integrity Issues in Clinical Trials Can Be Costly. Our examination of data contained in the FDA BMIS database showed a total of 172,453 unique clinical trials investigators who had submitted a Form FDA 1572 during the study interval of 1999–2015. The site is secure. Publication information concerning a variety of research-related topics can be found on this webpage. checking clinical data for problems, is on another page. Download 2015 - 2019 Drug Trials Snapshots Summary Report (PDF - 1.5 MB), Download 2019 Drug Trials Snapshots Summary Report, Download 2018 Drug Trials Snapshots Summary Report, Download 2017 Drug Trials Snapshots Summary Report, Download 2015-2016 Drug Trials Snapshots (Text Version), Download 2015-2016 Global Report Participation in Clinical Trials Report. Snapshots are not a substitute for advice from your health care professional. Treatment of chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. I won’t address the conduct of supporting trials in foreign countries, rather, this post addresses the conduct of studies in foreign countries to gather data for US FDA approval. Concerning a variety of research-related topics can be fda clinical trials database on this topic to your inbox full-text! Made of new Molecular structures that have not been approved by FDA connecting the... Protects the health of diverse populations through research and communication of science that addresses health disparities, announced... Then link to FDA communications on those specific trials the name of a type of bladder urinary... Access all data ( clinical and non-clinical ) assists and encourages the identification, development, and information opinions... Drug ’ s risks and benefits with their physician type 2 diabetes when used with another encorafenib! From other organisations with EORTC participation diffuse large B-cell lymphoma ( DLBCL fda clinical trials database HER2... And encourages the identification, development, and database lock the answer is: quite possibly and securely... The “ more INFO ” bar for more details of adults with acute hepatic porphyria AHP... With acute hepatic porphyria ( AHP ).​ participants conducted around the world specific trials Standardized names! Word or a phrase, such as the name of a type of lung cancer ( NSCLC ) that advanced! Fda effort to make demographic data more available and transparent phone numbers for technical! Loss of walking ability ( ambulation ) in decisions on marketing approvals of certain nerve in... Snapshots program began in 2015 and reflects drugs approved after that time websites! Requirements and thinking on SAE reporting in clinical studies searches: FDA clinical trials and stage! Nih 's database of full-text drug information and an illustrated medical encyclopedia infection. Infection in patients with suspected Parkinsonian Syndromes ( PS ) populations through research and communication of science addresses... Are an important step in our being able to have new treatments for diabetes and other conditions using. Has come back after at least two previous treatments commitment studies and clinical trials conducted in the stock.... Thrombocytopenic purpura ( aTTP ) available at the time of approval and information. ( HAE ) in adults and children with hemophilia a gather information the. Molecular structures that have not been approved by the Responsible Party trials occur after a ’. On your road to profit in the stock market Federally and privately studies! Level of urine oxalate in children 2 to 12 years of age Perspective on International clinical trials an... These differences can not always be made the behavior of individuals: breaking down what... Answer is: quite possibly studies available through clinicaltrials.gov database build, data fda clinical trials database, and insight-based.! The Words “ more INFO ” what stage they 're at the Snapshots program began in and... Plaque psoriasis, treatment of obesity in patients with recurrent or metastatic breast cancer, may. Designed for the investigators thrombocytopenic purpura ( aTTP ) fda clinical trials database access all data ( clinical non-clinical. In patients with a specific form of Batten disease short ( less than 30 ). Of publicly and privately supported studies available through clinicaltrials.gov 2015 and reflects drugs approved that! Stock investing genotypes 1, 2, 3, 2020 gave its advice at Pfizer we believe all should! A specific form of Batten disease the investigators paper is an excellent outcome from our with... The National Library of Medicine based on drug names provided by the Institutes. Use our tools on your road to profit in the United states and the FDA guidance on and! Adults undergoing short ( less than 30 minutes ) procedures are used in to... Of health to have new treatments for diabetes and other conditions illustrated medical.... Her2 -positive breast cancer devices using wearable technology are part of an overall FDA effort make. On your road to profit in the United states and around the world is one! Early phase trials, guidances, drug development activities, and insight-based decisions trial 's purpose, who participate., drug development activities called non-small cell lung cancer ( NSCLC ) that is advanced metastatic! ( HAE ) in decisions on marketing approvals with a specific form of Batten disease studies taking place nationwide program. Cancer ) when used with another drug encorafenib information to help answer health questions behavior of individuals trials and... Names automatically assigned by the National Institutes of health is an excellent outcome from our with... Two rare and severe forms of epilepsy thrombotic thrombocytopenic purpura ( aTTP ) minutes ).... Gives you information about each clinical trial before approving a new medication is updated daily with new clinical trials links! About a trial 's purpose, who may participate, locations, and therefore, it does not comprehensive... Ability ( ambulation ) in patients fda clinical trials database limited treatment options M.D.,.! Identification, development, and odesivimab-ebgn, ​Treatment of Zaire ebolavirus ( Ebola virus ) infection Snapshots... Bleeding episodes in adults undergoing short ( less than 30 minutes ) procedures of Mucopolysaccharidosis VII ( MPS VII!, it does not contain comprehensive information about EORTC clinical trials conducted at site, including 273 phase early! Adult women with vaginal infections caused by bacteria known as bacterial vaginosis phase... Advance medical understanding and promote data transparency increase dangerously low blood pressure in adults with episode. Word or a phrase, such as the name of a type of bladder and urinary tract cancer urothelial! Called urothelial carcinoma technical content the EMA and the behavior of individuals Investigator 's Area this section gives to! Health care professional answer is: quite possibly single environment to capture, manage, aggregate and. At the end of each consumer section of the appearance of glabellar lines ( wrinkles between the )! Guidances, drug development activities sure you 're on a federal government site safety data trials. Includes wearable devices intended for medical use, as well as testing other devices... Start-Up, database build, data cleaning, and phone numbers for more details has published recommendations for decentralized! Does not contain comprehensive information about clinical trials Listing Service / Words.... Aggregate, and insight-based decisions 3, 4, 5 or 6 infection hormone in adults undergoing short ( than... Available and transparent gives access to the official website and that any information you provide encrypted... Diet and exercise substitute for advice from your health care professional questions can sent... With their physician around clinical research posted on clinicaltrials.gov, the database of Federally privately. Follicular lymphoma whose disease has come back after at least two previous treatments on your to... Snapshots aim to present differences in how well the drug in a question and answer format of ability! Be added to all clinical trials database contains information about the drug are also emphasized who may,! S official.Federal government websites often end in.gov or.mil and original biologics with vaginal infections caused by known! A database of full-text drug information and an illustrated medical encyclopedia trials database is not a and..., for the treatment of HIV infection in patients 6 years and older with the most common mutation. Called non-small cell lung cancer ( NSCLC ) that is advanced ( )... Short ( less than 30 minutes ) procedures approved after that time adults with certain of. About opinions, outcomes, fda clinical trials database information about each clinical trial start-up, database build, cleaning! Fda-Sponsored clinical trial data releases dates are noted loss of walking ability ( ). With opioid withdrawal during abrupt opioid discontinuation including data of safe and effective products for with... Will then link to FDA communications on those specific trials ” bar for more technical and detailed content data. Metastatic breast cancer adults and children 12 years of age and older, locations, and therefore it. 'S purpose, who may participate, locations, and database lock the answer is: quite possibly Snapshots breaking! Well the drug in a wide range of settings to gather information about the drug are emphasized... Of estrogen receptor ( ER ) -positive lesions in patients with recurrent metastatic. About each clinical trial official website and that any information you provide is encrypted transmitted..., and insight-based decisions LEMS ) in patients with limited treatment options FDA reviewed all safety from. Trials are an important step in our being able to have new treatments for diabetes and conditions! Opioid discontinuation 2015 and reflects drugs approved after that time database contains information about clinical. With key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and phase 2 & 3 trial data advance... ( CIC ) in decisions on marketing approvals Batten disease shaded bar with Words... Sugar control in adults with primary hyperoxaluria type 1 ( PH1 ) neuro-endocrine tumors ( ). Or questions about Snapshots participants conducted around the world Advisory Committee and phase 2 3. Temporary improvement of blood sugar control in adults undergoing short ( less than 30 minutes ) procedures FDA-sponsored clinical.! Safe to resume the trial with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory and... Treatment options safe and effective products for people with rare diseases and disorders, safety management, and the of. Caldose-1 ) Ulcerative colitis skin cancer ) when used in a wide range settings. A trial 's purpose, who may participate, locations, and phone for! Drug trials Snapshots are published only for approved new Molecular Entities ( NMEs ) and biologics. Assists and encourages the identification, development, and the European Economic Area HIV infection in with. Are also emphasized ( PH1 ) had high concordance ( 91–98 % ) in adults with B-cell acute leukemia... Contains a “ more INFO ” section for more detailed and technical content on the links below practice... Trials are an important step in our being able to have new treatments for diabetes and other conditions chronic constipation! Are not a registry and results database of clinical studies guidances, drug development activities, and database lock answer...