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Wyszukujesz frazę ""Drug Approval"" wg kryterium: Temat


Tytuł :
Characteristics and Outcomes of Products Seeking Competitive Generic Therapy Designation and Exclusivity.
Autorzy :
Chahal HS; Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland.
Fowler AC; Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland.
Patel R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Shimer M; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
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Źródło :
JAMA [JAMA] 2021 Nov 09; Vol. 326 (18), pp. 1863-1865.
Typ publikacji :
Journal Article
MeSH Terms :
Drugs, Generic*
Drug Approval/*statistics & numerical data
Cross-Sectional Studies ; Drug Approval/legislation & jurisprudence ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Eua for Regen-Cov Now Includes COVID-19 Postexposure Prophylaxis.
Autorzy :
Aschenbrenner DS; Diane S. Aschenbrenner is a former member of the faculty at Notre Dame of Maryland University and the Johns Hopkins University School of Nursing. She coordinates Drug Watch: .
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Źródło :
The American journal of nursing [Am J Nurs] 2021 Nov 01; Vol. 121 (11), pp. 22.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Post-Exposure Prophylaxis*
Antibodies, Monoclonal, Humanized/*therapeutic use
COVID-19/*prevention & control
Adolescent ; Adult ; Aged ; Child ; Drug Combinations ; Humans ; Middle Aged ; United States ; Young Adult
Czasopismo naukowe
Tytuł :
Statins No Longer Contraindicated in Pregnancy.
Autorzy :
Aschenbrenner DS; Diane S. Aschenbrenner is a former member of the faculty at Notre Dame of Maryland University and the Johns Hopkins University School of Nursing. She coordinates Drug Watch: .
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Źródło :
The American journal of nursing [Am J Nurs] 2021 Nov 01; Vol. 121 (11), pp. 22.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
United States Food and Drug Administration*
Atorvastatin/*therapeutic use
Cardiovascular Diseases/*drug therapy
Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use
Pravastatin/*therapeutic use
Contraindications ; Female ; Humans ; Pregnancy ; United States
Czasopismo naukowe
Tytuł :
Paying for Cancer Drugs That Prove Their Benefit.
Autorzy :
Frank RG; Schaeffer Initiative on Health Policy, The Brookings Institution, Washington, DC.
Emanuel EJ; Department of Medical Ethics and Health Policy, Perelman School of Medicine and Wharton School, University of Pennsylvania, Philadelphia.
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Źródło :
JAMA [JAMA] 2021 Oct 26; Vol. 326 (16), pp. 1579-1580.
Typ publikacji :
Journal Article
MeSH Terms :
Reimbursement Mechanisms*
Antineoplastic Agents/*economics
Drug Approval/*economics
Neoplasms/*drug therapy
Antineoplastic Agents/therapeutic use ; Centers for Medicare and Medicaid Services, U.S. ; Clinical Trials as Topic ; Drug Approval/methods ; Drug Costs ; Humans ; Medicare Part B/economics ; Models, Theoretical ; Neoplasms/mortality ; Standard of Care ; Treatment Outcome ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
The Drug-Dosing Conundrum in Oncology - When Less Is More.
Autorzy :
Shah M; From the Office of Oncologic Diseases (M.S.) and the Division of Cancer Pharmacology II, Office of Clinical Pharmacology (A.R.), Center for Drug Evaluation and Research, and the Oncology Center of Excellence (M.R.T., R.P.), Food and Drug Administration, Silver Spring, MD.
Rahman A; From the Office of Oncologic Diseases (M.S.) and the Division of Cancer Pharmacology II, Office of Clinical Pharmacology (A.R.), Center for Drug Evaluation and Research, and the Oncology Center of Excellence (M.R.T., R.P.), Food and Drug Administration, Silver Spring, MD.
Theoret MR; From the Office of Oncologic Diseases (M.S.) and the Division of Cancer Pharmacology II, Office of Clinical Pharmacology (A.R.), Center for Drug Evaluation and Research, and the Oncology Center of Excellence (M.R.T., R.P.), Food and Drug Administration, Silver Spring, MD.
Pazdur R; From the Office of Oncologic Diseases (M.S.) and the Division of Cancer Pharmacology II, Office of Clinical Pharmacology (A.R.), Center for Drug Evaluation and Research, and the Oncology Center of Excellence (M.R.T., R.P.), Food and Drug Administration, Silver Spring, MD.
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Źródło :
The New England journal of medicine [N Engl J Med] 2021 Oct 14; Vol. 385 (16), pp. 1445-1447. Date of Electronic Publication: 2021 Oct 09.
Typ publikacji :
Journal Article
MeSH Terms :
Clinical Trials as Topic*
Drug Approval*
Antineoplastic Agents/*administration & dosage
Neoplasms/*drug therapy
Dose-Response Relationship, Drug ; Humans ; Medical Oncology ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
A Middle Ground for Accelerated Drug Approval-Lessons From Aducanumab.
Autorzy :
Emanuel EJ; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
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Źródło :
JAMA [JAMA] 2021 Oct 12; Vol. 326 (14), pp. 1367-1368.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*/methods
Alzheimer Disease/*drug therapy
Antibodies, Monoclonal, Humanized/*therapeutic use
Humans ; Time Factors ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors.
Autorzy :
Yekedüz E; Department of Medical Oncology, Ankara University School of Medicine, Ankara, Turkey.
Trapani D; European Institute of Oncology, IRCCS, Milan, Italy.
Xu W; Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
de Vries EGE; University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Labaki C; Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Gyawali B; Queen's University School of Medicine, Cancer Research Institute, Kingston, Ontario, Canada.
Gulati S; Division of Hematology and Oncology, University of Cincinnati, Cincinnati, Ohio, USA.
Nabhan C; Caris Life Sciences, Irving, Texas, USA.
Utkan G; Department of Medical Oncology, Ankara University School of Medicine, Ankara, Turkey.
Curigliano G; European Institute of Oncology, IRCCS, Milan, Italy.; Department of Oncology and Hematology (DIPO), University of Milan, Milan, Italy.
Choueiri TK; Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Ürün Y; Department of Medical Oncology, Ankara University School of Medicine, Ankara, Turkey.
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Źródło :
International journal of cancer [Int J Cancer] 2021 Oct 01; Vol. 149 (7), pp. 1455-1462. Date of Electronic Publication: 2021 Jul 05.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Patient Selection*
Antineoplastic Agents/*therapeutic use
Ethnic Groups/*statistics & numerical data
Neoplasms/*drug therapy
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Clinical Trials, Phase III as Topic ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/pathology ; United States ; United States Food and Drug Administration ; Young Adult
Czasopismo naukowe
Tytuł :
Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.
Autorzy :
Egilman A; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
Wallach JD; Department of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, USA.
Puthumana J; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Zhang AD; Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Schwartz JL; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.
Ross JS; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. .; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA. .; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA. .
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Źródło :
Journal of general internal medicine [J Gen Intern Med] 2021 Oct; Vol. 36 (10), pp. 3281-3284. Date of Electronic Publication: 2021 Jun 15.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Drug Approval*
Vaccines*/adverse effects
Humans ; Product Surveillance, Postmarketing ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals.
Autorzy :
Park K; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Virparia R; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Green DJ; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
Epps C; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
Wharton GT; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
McCune SK; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Oct; Vol. 110 (4), pp. 997-1003. Date of Electronic Publication: 2021 Jun 14.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Infant*
Infant, Newborn*
Orphan Drug Production*
Humans ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
FDA Breakthrough Therapy Designation-Trial Design and More - Commentary.
Autorzy :
Corrigan-Curay J; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Stein P; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Oct; Vol. 110 (4), pp. 869-870. Date of Electronic Publication: 2021 Aug 14.
Typ publikacji :
Journal Article; Comment
MeSH Terms :
Drug Approval*
Humans ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Achievements and challenges of the Sakigake designation system in Japan.
Autorzy :
Tanaka M; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Idei M; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Sakaguchi H; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Kato R; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Sato D; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Sawanobori K; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Kawarasaki S; Office of New Drug 2, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Hata T; Office of New Drug 3, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yoshizaki A; Office of New Drug 4, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Nakamura M; Office of New Drug 5, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Ikuma M; Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
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Źródło :
British journal of clinical pharmacology [Br J Clin Pharmacol] 2021 Oct; Vol. 87 (10), pp. 4027-4035. Date of Electronic Publication: 2021 Mar 22.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Drug Development*
Humans ; Japan ; Retrospective Studies
Czasopismo naukowe
Tytuł :
Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed.
Autorzy :
Pregelj L; School of Chemistry and Molecular Biosciences, University of Queensland Business School, The University of Queensland, St Lucia, Queensland, Australia.
Hine DC; Kemmy Business School, University of Limerick, Limerick, Ireland.
Kesselheim AS; Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Darrow JJ; Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.; Department of Law and Taxation, Bentley University, Waltham, Massachusetts, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Oct; Vol. 110 (4), pp. 1018-1024. Date of Electronic Publication: 2021 Jul 01.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Clinical Trials as Topic*
Drug Approval*
Drug Development*
United States Food and Drug Administration*
Drug and Narcotic Control ; Humans ; Time Factors ; United States
Czasopismo naukowe
Tytuł :
Prescription medications for use in pregnancy-perspective from the US Food and Drug Administration.
Autorzy :
Wesley BD; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD. Electronic address: .
Sewell CA; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Chang CY; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Hatfield KP; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Nguyen CP; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
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Źródło :
American journal of obstetrics and gynecology [Am J Obstet Gynecol] 2021 Jul; Vol. 225 (1), pp. 21-32.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*/legislation & jurisprudence
Drug Approval*/statistics & numerical data
Pregnancy*
Prescription Drugs*
United States Food and Drug Administration*
Animals ; Clinical Trials as Topic ; Female ; Fetus/drug effects ; Humans ; Lactation ; Pregnancy Complications/drug therapy ; Risk Assessment ; Teratogens ; United States
Czasopismo naukowe
Tytuł :
Oncology Products in the European Union: An Analysis of Regulatory Approvals with a CHMP Oral Explanation.
Autorzy :
Oger A; MSD Europe Inc, Clos du Lynx 5, 1200, Brussels, Belgium. .
Torqui A; MSD, Oss, The Netherlands.
Kester R; Merck & Co., Inc., Rahway, NJ, USA.
Wissink S; MSD, Oss, The Netherlands.
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Źródło :
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 Sep; Vol. 55 (5), pp. 1036-1044. Date of Electronic Publication: 2021 May 26.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
European Union ; Humans
Czasopismo naukowe
Tytuł :
New Drugs Approved in 2020.
Autorzy :
Ebied AM; Department of Clinical Sciences, High Point University Fred Wilson School of Pharmacy, NC.
Elmariah H; Ross University School of Medicine, Bridgetown, Barbados.
Cooper-DeHoff RM; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville. Electronic address: .
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Źródło :
The American journal of medicine [Am J Med] 2021 Sep; Vol. 134 (9), pp. 1096-1100. Date of Electronic Publication: 2021 Apr 30.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*/methods
Drug Approval*/organization & administration
Drug Therapy/trends ; Humans ; Pharmaceutical Preparations/classification ; Rare Diseases/drug therapy ; United States
Czasopismo naukowe
Tytuł :
Editorial: Global Regulatory Initiatives Deliver Accelerated Approval of the First Bispecific Therapeutic Monoclonal Antibody for Advanced Non-Small Cell Lung Cancer (NSCLC).
Autorzy :
Parums DV; Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.
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Źródło :
Medical science monitor : international medical journal of experimental and clinical research [Med Sci Monit] 2021 Sep 27; Vol. 27, pp. e934854. Date of Electronic Publication: 2021 Sep 27.
Typ publikacji :
Editorial
MeSH Terms :
Drug Approval*
Antibodies, Bispecific/*administration & dosage
Carcinoma, Non-Small-Cell Lung/*drug therapy
Lung Neoplasms/*drug therapy
Carcinoma, Non-Small-Cell Lung/diagnosis ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/metabolism ; ErbB Receptors/genetics ; ErbB Receptors/metabolism ; High-Throughput Nucleotide Sequencing ; Humans ; Mutation ; Proto-Oncogene Proteins c-met/genetics ; Proto-Oncogene Proteins c-met/metabolism ; United States ; United States Food and Drug Administration
Opinia redakcyjna
Tytuł :
Raising the bar for using surrogate endpoints in drug regulation and health technology assessment.
Autorzy :
Dawoud D; Science, Evidence and Analytics Directorate, Science Policy and Research Programme, National Institute for Health and Care Excellence, London, UK.
Naci H; Department of Health Policy, London School of Economics and Political Science, London, UK.
Ciani O; Centre for Research on Health and Social Care Management, SDA Bocconi, Milan, Italy.; College of Medicine and Health, University of Exeter, Exeter, UK.
Bujkiewicz S; Biostatistics Research Group, Department of Health Sciences, University of Leicester, Leicester, UK.
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Źródło :
BMJ (Clinical research ed.) [BMJ] 2021 Sep 15; Vol. 374, pp. n2191. Date of Electronic Publication: 2021 Sep 15.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Technology Assessment, Biomedical/*standards
Biomarkers ; Humans ; Technology Assessment, Biomedical/methods
Czasopismo naukowe

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