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


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 :
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines.
Autorzy :
Garsen M; Zwiers Regulatory Consultancy, Pivot Park, Kloosterstraat 9, 5349 AB, Oss, The Netherlands. .
Steenhof M; Zwiers Regulatory Consultancy, Pivot Park, Kloosterstraat 9, 5349 AB, Oss, The Netherlands.
Zwiers A; Zwiers Regulatory Consultancy, Pivot Park, Kloosterstraat 9, 5349 AB, Oss, The Netherlands.
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Źródło :
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 Jul; Vol. 55 (4), pp. 633-642. Date of Electronic Publication: 2021 Feb 04.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Antineoplastic Agents*
Drug Approval*
European Union ; Humans ; Marketing
Czasopismo naukowe
Tytuł :
US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy.
Autorzy :
Daizadeh I; Takeda Pharmaceuticals, 40 Landsdowne St, Cambridge, MA, 02139, USA. .
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Źródło :
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 Jul; Vol. 55 (4), pp. 743-754. Date of Electronic Publication: 2021 Mar 30.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*
Policy*
United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities.
Autorzy :
Feng C; Pharmaceutical Industry Fellowship Program, Northeastern University, 360 Huntington Ave, R218 140 The Fenway, Boston, MA, 02115, USA. .
Virparia R; Division of Pharmacotherapy & Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Mui ET; Division of Pharmacotherapy & Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA.
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Źródło :
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 Jul; Vol. 55 (4), pp. 881-888. Date of Electronic Publication: 2021 Apr 28.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*
Pharmaceutical Preparations*
Marketing ; Pilot Projects ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
An introduction to risk evaluation and mitigation strategies.
Autorzy :
Dohm J; Covington & Burling LLP, DC, United States.
Ji M; Covington & Burling LLP, DC, United States. Electronic address: .
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Źródło :
Contraception [Contraception] 2021 Jul; Vol. 104 (1), pp. 4-7. Date of Electronic Publication: 2021 Apr 24.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*
Risk Evaluation and Mitigation*
United States Food and Drug Administration*
Abortifacient Agents, Steroidal ; Drug and Narcotic Control ; Humans ; Mifepristone ; United States
Czasopismo naukowe
Tytuł :
An EUA for sotrovimab for treatment of COVID-19.
Źródło :
The Medical letter on drugs and therapeutics [Med Lett Drugs Ther] 2021 Jun 28; Vol. 63 (1627), pp. 97-xx98.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Antibodies, Monoclonal, Humanized/*therapeutic use
Antiviral Agents/*therapeutic use
COVID-19/*drug therapy
SARS-CoV-2/*drug effects
Antibodies, Monoclonal, Humanized/adverse effects ; Antiviral Agents/adverse effects ; COVID-19/diagnosis ; COVID-19/virology ; Humans ; SARS-CoV-2/pathogenicity ; United States ; United States Food and Drug Administration
SCR Protocol :
COVID-19 drug treatment
Czasopismo naukowe
Tytuł :
Tozinameran (BNT162b2) Vaccine: The Journey from Preclinical Research to Clinical Trials and Authorization.
Autorzy :
Khehra N; Saint James School of Medicine, Arnos Vale, Saint Vincent and the Grenadines.
Padda I; University of Washington, Seattle, WA, USA.
Jaferi U; All Saints University School of Medicine, Roseau, Dominica.
Atwal H; Saint James School of Medicine, Arnos Vale, Saint Vincent and the Grenadines.
Narain S; Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Tampa Bay Campus, Clearwater, FL, USA.
Parmar MS; Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Tampa Bay Campus, Clearwater, FL, USA. .
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Źródło :
AAPS PharmSciTech [AAPS PharmSciTech] 2021 Jun 07; Vol. 22 (5), pp. 172. Date of Electronic Publication: 2021 Jun 07.
Typ publikacji :
Journal Article; Review
MeSH Terms :
COVID-19/*prevention & control
COVID-19 Vaccines/*administration & dosage
Clinical Trials as Topic/*methods
Drug Approval/*methods
SARS-CoV-2/*drug effects
Animals ; Antibodies, Neutralizing/drug effects ; Antibodies, Neutralizing/metabolism ; COVID-19/epidemiology ; COVID-19/metabolism ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/metabolism ; Clinical Trials as Topic/legislation & jurisprudence ; Drug Approval/legislation & jurisprudence ; Drug Evaluation, Preclinical/methods ; Exanthema/chemically induced ; Female ; Humans ; Male ; SARS-CoV-2/metabolism ; Spike Glycoprotein, Coronavirus/drug effects ; Spike Glycoprotein, Coronavirus/metabolism ; Vaccination/legislation & jurisprudence ; Vaccination/methods
Czasopismo naukowe
Tytuł :
Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada.
Autorzy :
Lythgoe MP; Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, United Kingdom.
Middleton P; Department of Metabolism, Digestion and Reproduction, Imperial College London, St Mary's Hospital, United Kingdom.
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Źródło :
JAMA network open [JAMA Netw Open] 2021 Jun 01; Vol. 4 (6), pp. e2114531. Date of Electronic Publication: 2021 Jun 01.
Typ publikacji :
Journal Article
MeSH Terms :
COVID-19 Vaccines/*therapeutic use
Drug Approval/*statistics & numerical data
Immunization Programs/*standards
COVID-19 Vaccines/supply & distribution ; Canada ; Drug Approval/methods ; Europe ; Humans ; Immunization Programs/statistics & numerical data ; Quality Improvement ; United States ; United States Food and Drug Administration/organization & administration ; United States Food and Drug Administration/statistics & numerical data
Czasopismo naukowe
Tytuł :
New drugs and pharmacological interactions in real life.
Autorzy :
Stathis A; New Drugs Development Unit, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
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Źródło :
Hematological oncology [Hematol Oncol] 2021 Jun; Vol. 39 Suppl 1, pp. 78-82.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*
Antineoplastic Agents/*therapeutic use
Hematologic Neoplasms/*drug therapy
Lymphoproliferative Disorders/*drug therapy
Antineoplastic Agents/adverse effects ; Drug Interactions ; Humans
Czasopismo naukowe
Tytuł :
Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health.
Autorzy :
Zuckerman DM; Diana M. Zuckerman is president of the National Center for Health Research, Washington, DC.
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Źródło :
American journal of public health [Am J Public Health] 2021 Jun; Vol. 111 (6), pp. 1065-1069.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*
Public Health*
COVID-19/*prevention & control
COVID-19 Vaccines/*administration & dosage
Government Programs/*standards
United States Food and Drug Administration/*standards
Drug Development/standards ; Humans ; United States
Czasopismo naukowe
Tytuł :
Are phase III trials still important for FDA drug approval?
Autorzy :
Percival MM; Division of Hematology, Department of Medicine, University of Washington, Seattle, WA, USA.; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Estey EH; Division of Hematology, Department of Medicine, University of Washington, Seattle, WA, USA.; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
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Źródło :
Leukemia & lymphoma [Leuk Lymphoma] 2021 Jun; Vol. 62 (6), pp. 1287-1288. Date of Electronic Publication: 2021 Mar 10.
Typ publikacji :
Journal Article; Comment
MeSH Terms :
Drug Approval*
Hematologic Neoplasms*
Humans
Czasopismo naukowe
Tytuł :
Assessment of Data Supporting the Efficacy of New Antibiotics for Treating Infections Caused by Multidrug-resistant Bacteria.
Autorzy :
Yahav D; Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.; Sackler Faculty of Medicine, Tel-Aviv University, Ramat Aviv, Tel Aviv, Israel.
Tau N; Sackler Faculty of Medicine, Tel-Aviv University, Ramat Aviv, Tel Aviv, Israel.; Department of Diagnostic Imaging, Chaim Sheba Medical Center, Ramat Gan, Israel.
Shepshelovich D; Sackler Faculty of Medicine, Tel-Aviv University, Ramat Aviv, Tel Aviv, Israel.; Medicine I, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
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Źródło :
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2021 Jun 01; Vol. 72 (11), pp. 1968-1974.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Pneumonia, Bacterial*/drug therapy
Anti-Bacterial Agents/therapeutic use ; Drug Resistance, Multiple, Bacterial ; Humans ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
The impact of pharmaceutical innovation on the longevity and hospitalization of New Zealand cancer patients, 1998-2017.
Autorzy :
Lichtenberg FR; Graduate School of Business, Columbia University (New York, NY, USA), National Bureau of Economic Research, and CESifo Columbia University, New York, NY, USA.
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Źródło :
Expert review of pharmacoeconomics & outcomes research [Expert Rev Pharmacoecon Outcomes Res] 2021 Jun; Vol. 21 (3), pp. 476-477. Date of Electronic Publication: 2021 Mar 15.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Antineoplastic Agents/*administration & dosage
Hospitalization/*statistics & numerical data
Neoplasms/*drug therapy
Age Distribution ; Aged ; Aged, 80 and over ; Antineoplastic Agents/economics ; Cost-Benefit Analysis ; Diffusion of Innovation ; Hospitalization/economics ; Humans ; Longevity/drug effects ; Longitudinal Studies ; Neoplasms/economics ; New Zealand ; Quality-Adjusted Life Years ; Survival Rate
Czasopismo naukowe
Tytuł :
Level of evidence for FDA drug approvals in pivotal clinical trials of hematological malignancies.
Autorzy :
Al Hadidi S; Department of Hematology and Oncology, The Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX, USA.
Ramos CA; Department of Hematology and Oncology, The Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX, USA.
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Źródło :
Leukemia & lymphoma [Leuk Lymphoma] 2021 Jun; Vol. 62 (6), pp. 1522-1524. Date of Electronic Publication: 2021 Jan 24.
Typ publikacji :
Letter; Research Support, N.I.H., Extramural
MeSH Terms :
Drug Approval*
Hematologic Neoplasms*/drug therapy
Humans ; United States ; United States Food and Drug Administration
Raport
Tytuł :
WHO approval of Chinese CoronaVac COVID vaccine will be crucial to curbing pandemic.
Autorzy :
Mallapaty S
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Źródło :
Nature [Nature] 2021 Jun; Vol. 594 (7862), pp. 161-162.
Typ publikacji :
Wiadomości
MeSH Terms :
Drug Approval*
Immunization Programs*
COVID-19/*prevention & control
COVID-19 Vaccines/*standards
Pandemics/*prevention & control
World Health Organization/*organization & administration
Antibodies, Viral/immunology ; COVID-19/immunology ; COVID-19/mortality ; COVID-19/virology ; COVID-19 Vaccines/immunology ; China/epidemiology ; Developing Countries ; Humans ; Pandemics/statistics & numerical data ; SARS-CoV-2/immunology ; Vaccines, Inactivated/immunology ; Vaccines, Inactivated/standards
SCR Organism :
SARS-CoV-2 variants
Periodyk
Tytuł :
"Dangling" Accelerated Approvals in Oncology.
Autorzy :
Beaver JA; From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
Pazdur R; From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
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Źródło :
The New England journal of medicine [N Engl J Med] 2021 May 06; Vol. 384 (18), pp. e68. Date of Electronic Publication: 2021 Apr 21.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
United States Food and Drug Administration*
Antibodies, Monoclonal/*therapeutic use
Antineoplastic Agents/*therapeutic use
B7-H1 Antigen/*antagonists & inhibitors
Programmed Cell Death 1 Receptor/*antagonists & inhibitors
Clinical Trials as Topic ; Humans ; Medical Oncology ; United States
Czasopismo naukowe
Tytuł :
A Validated LC-MS/MS Assay for the Simultaneous Quantification of the FDA-Approved Anticancer Mixture (Encorafenib and Binimetinib): Metabolic Stability Estimation.
Autorzy :
Attwa MW; Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.; Students' University Hospital, The Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Darwish HW; Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo 11562, Egypt.
Al-Shakliah NS; Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
Kadi AA; Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
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Źródło :
Molecules (Basel, Switzerland) [Molecules] 2021 May 05; Vol. 26 (9). Date of Electronic Publication: 2021 May 05.
Typ publikacji :
Journal Article; Validation Study
MeSH Terms :
Drug Approval*
Tandem Mass Spectrometry*
Antineoplastic Agents/*analysis
Benzimidazoles/*analysis
Benzimidazoles/*metabolism
Carbamates/*analysis
Carbamates/*metabolism
Sulfonamides/*analysis
Sulfonamides/*metabolism
Benzimidazoles/chemistry ; Calibration ; Carbamates/chemistry ; Chromatography, Liquid ; Computer Simulation ; Drug Stability ; Humans ; Microsomes, Liver/metabolism ; Quality Control ; Reproducibility of Results ; Sulfonamides/chemistry ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility.
Autorzy :
Alexander GC; Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Emerson S; Department of Biostatistics, University of Washington, Seattle.
Kesselheim AS; Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
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Źródło :
JAMA [JAMA] 2021 May 04; Vol. 325 (17), pp. 1717-1718.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Alzheimer Disease/*drug therapy
Antibodies, Monoclonal, Humanized/*therapeutic use
Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Humans ; Medical Futility ; Randomized Controlled Trials as Topic ; Treatment Failure ; United States ; United States Food and Drug Administration
Czasopismo naukowe

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