Informacja

Drogi użytkowniku, aplikacja do prawidłowego działania wymaga obsługi JavaScript. Proszę włącz obsługę JavaScript w Twojej przeglądarce.

Przeglądasz jako GOŚĆ

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


Tytuł :
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.
Autorzy :
Hwang TJ; 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, MA, USA .; Laboratory for Technology, Markets and Regulation, University of Zurich, Zurich, Switzerland.
Ross JS; Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.; Department of Health Policy and Management, Yale University School of Public Health, New Haven, CT, USA.; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
Vokinger KN; Laboratory for Technology, Markets and Regulation, University of Zurich, Zurich, Switzerland.; Institute of Law, University of Zurich, Zurich, Switzerland.
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, MA, USA.
Pokaż więcej
Źródło :
BMJ (Clinical research ed.) [BMJ] 2020 Oct 07; Vol. 371, pp. m3434. Date of Electronic Publication: 2020 Oct 07.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*/methods
Drug Approval*/statistics & numerical data
Drug Evaluation*/methods
Drug Evaluation*/statistics & numerical data
Drug Information Services*/organization & administration
Drug Information Services*/standards
Drug Information Services*/statistics & numerical data
Information Dissemination*
Product Surveillance, Postmarketing*/methods
Product Surveillance, Postmarketing*/statistics & numerical data
Europe ; Humans ; Program Development ; Quality Improvement ; Retrospective Studies ; United States
Czasopismo naukowe
Tytuł :
Up Is Down - Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval.
Autorzy :
Avorn J; From the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School - both in Boston.
Kesselheim AS; From the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School - both in Boston.
Pokaż więcej
Źródło :
The New England journal of medicine [N Engl J Med] 2020 Oct 29; Vol. 383 (18), pp. 1706-1708. Date of Electronic Publication: 2020 Sep 15.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Coronavirus Infections/*prevention & control
Drug Industry/*trends
Pandemics/*prevention & control
Pneumonia, Viral/*prevention & control
Viral Vaccines/*standards
Betacoronavirus ; Humans ; Politics ; United States ; United States Food and Drug Administration
SCR Disease Name :
COVID-19
Czasopismo naukowe
Tytuł :
Emergency Use Authorizations During the COVID-19 Pandemic: Lessons From Hydroxychloroquine for Vaccine Authorization and Approval.
Autorzy :
Thomson K; American Medical Association, Washington, DC.
Nachlis H; Department of Government, Rockefeller Center for Public Policy, Dartmouth College, Hanover, New Hampshire.
Pokaż więcej
Źródło :
JAMA [JAMA] 2020 Oct 06; Vol. 324 (13), pp. 1282-1283.
Typ publikacji :
Journal Article
MeSH Terms :
Compassionate Use Trials*
Drug Approval*
Viral Vaccines*
Coronavirus Infections/*drug therapy
Hydroxychloroquine/*therapeutic use
Pneumonia, Viral/*drug therapy
Betacoronavirus ; Coronavirus Infections/prevention & control ; Humans ; Pandemics/prevention & control ; Pneumonia, Viral/prevention & control ; United States ; United States Food and Drug Administration
SCR Disease Name :
COVID-19
Czasopismo naukowe
Tytuł :
Remdesivir emergency approvals: a comparison of the U.S., Japanese, and EU systems.
Autorzy :
Saint-Raymond A; International Affairs Division, European Medicines Agency, Amsterdam, EU.
Sato J; Office of International Programs, Pharmaceutical and Medical Devices Agency , Tokyo, Japan.
Kishioka Y; Office of International Programs, Pharmaceutical and Medical Devices Agency , Tokyo, Japan.
Teixeira T; International Affairs Division, European Medicines Agency, Amsterdam, EU.
Hasslboeck C; International Affairs Division, European Medicines Agency, Amsterdam, EU.
Kweder SL; European Office, Office of International Programs, Food and Drug Administration , Silver Spring, MD, USA.
Pokaż więcej
Źródło :
Expert review of clinical pharmacology [Expert Rev Clin Pharmacol] 2020 Oct; Vol. 13 (10), pp. 1095-1101. Date of Electronic Publication: 2020 Sep 29.
Typ publikacji :
Comparative Study; Journal Article; Review
MeSH Terms :
Drug Approval*
Adenosine Monophosphate/*analogs & derivatives
Alanine/*analogs & derivatives
Antiviral Agents/*therapeutic use
Coronavirus Infections/*drug therapy
Pneumonia, Viral/*drug therapy
Adenosine Monophosphate/therapeutic use ; Alanine/therapeutic use ; Betacoronavirus ; Compassionate Use Trials ; Emergency Medical Services ; European Union ; Humans ; Japan ; Pandemics ; United States
SCR Disease Name :
COVID-19
Czasopismo naukowe
Tytuł :
Assessing the Safety of Glucose-Lowering Drugs - A New Focus for the FDA.
Autorzy :
Chong WH; From the Food and Drug Administration, Silver Spring, MD.
Yanoff LB; From the Food and Drug Administration, Silver Spring, MD.
Andraca-Carrera E; From the Food and Drug Administration, Silver Spring, MD.
Thanh Hai M; From the Food and Drug Administration, Silver Spring, MD.
Pokaż więcej
Źródło :
The New England journal of medicine [N Engl J Med] 2020 Sep 24; Vol. 383 (13), pp. 1199-1202.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Cardiovascular Diseases/*chemically induced
Diabetes Mellitus, Type 2/*drug therapy
Hypoglycemic Agents/*adverse effects
Controlled Clinical Trials as Topic/standards ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Hypoglycemic Agents/therapeutic use ; Patient Safety ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Drug-drug interactions of newly approved small molecule inhibitors for acute myeloid leukemia.
Autorzy :
Megías-Vericat JE; Servicio de Farmacia, Área del Medicamento, Hospital Universitari i Politècnic La Fe. Av. Fernando Abril Martorell, 106, 46026, Valencia, Spain.
Solana-Altabella A; Servicio de Farmacia, Área del Medicamento, Hospital Universitari i Politècnic La Fe. Av. Fernando Abril Martorell, 106, 46026, Valencia, Spain.
Ballesta-López O; Servicio de Farmacia, Área del Medicamento, Hospital Universitari i Politècnic La Fe. Av. Fernando Abril Martorell, 106, 46026, Valencia, Spain.
Martínez-Cuadrón D; Servicio de Hematología y Hemoterapia, Hospital Universitari i Politècnic La Fe. Av. Fernando Abril Martorell, 106, 46026, Valencia, Spain.; CIBERONC, Instituto Carlos III, Madrid, Spain.
Montesinos P; Servicio de Hematología y Hemoterapia, Hospital Universitari i Politècnic La Fe. Av. Fernando Abril Martorell, 106, 46026, Valencia, Spain. .; CIBERONC, Instituto Carlos III, Madrid, Spain. .
Pokaż więcej
Źródło :
Annals of hematology [Ann Hematol] 2020 Sep; Vol. 99 (9), pp. 1989-2007. Date of Electronic Publication: 2020 Jul 18.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*
Antineoplastic Agents/*blood
Cytochrome P-450 CYP3A Inhibitors/*blood
Drug Interactions/*physiology
Leukemia, Myeloid, Acute/*blood
Leukemia, Myeloid, Acute/*drug therapy
Antineoplastic Agents/adverse effects ; Benzimidazoles/adverse effects ; Benzimidazoles/blood ; Bridged Bicyclo Compounds, Heterocyclic/adverse effects ; Bridged Bicyclo Compounds, Heterocyclic/blood ; Cytochrome P-450 CYP3A Inhibitors/adverse effects ; Drugs, Investigational/adverse effects ; Drugs, Investigational/metabolism ; Humans ; Long QT Syndrome/blood ; Long QT Syndrome/chemically induced ; Phenylurea Compounds/adverse effects ; Phenylurea Compounds/blood ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/blood ; Staurosporine/adverse effects ; Staurosporine/analogs & derivatives ; Staurosporine/blood ; Sulfonamides/adverse effects ; Sulfonamides/blood
Czasopismo naukowe
Tytuł :
Anticipating Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine Testing, Licensure, and Recommendations for Use.
Autorzy :
Edwards KM; Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, TN. Electronic address: .
Orenstein WA; Departments of Medicine and Pediatrics, Emory University School of Medicine, Atlanta, GA.
Pokaż więcej
Źródło :
The Journal of pediatrics [J Pediatr] 2020 Sep; Vol. 224, pp. 124-128. Date of Electronic Publication: 2020 Jun 19.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Coronavirus Infections/*prevention & control
Pandemics/*prevention & control
Pneumonia, Viral/*prevention & control
Viral Vaccines/*standards
Viral Vaccines/*therapeutic use
Betacoronavirus/immunology ; Child ; Clinical Trials as Topic ; Drug Industry ; Humans ; Patient Safety ; United States ; United States Food and Drug Administration
SCR Disease Name :
COVID-19
Czasopismo naukowe
Tytuł :
No Easy Answers in Allocating Unapproved COVID-19 Drugs Outside Clinical Trials.
Autorzy :
Webb J; New York University School of Medicine.
Shah L; Icahn School of Medicine at Mount Sinai.
Lynch HF; University of Pennsylvania Perelman School of Medicine.
Pokaż więcej
Źródło :
The American journal of bioethics : AJOB [Am J Bioeth] 2020 Sep; Vol. 20 (9), pp. W1-W4.
Typ publikacji :
Letter; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*
Health Care Rationing*
Coronavirus Infections/*drug therapy
Pneumonia, Viral/*drug therapy
Betacoronavirus ; Biomedical Research ; Coronavirus Infections/virology ; Decision Making ; Humans ; Pandemics ; Pneumonia, Viral/virology ; Prior Authorization ; United States
SCR Disease Name :
COVID-19
Raport
Tytuł :
In plasma OK, critics see politics, not science.
Autorzy :
Kupferschmidt K
Cohen J
Pokaż więcej
Źródło :
Science (New York, N.Y.) [Science] 2020 Aug 28; Vol. 369 (6507), pp. 1038-1039.
Typ publikacji :
Wiadomości
MeSH Terms :
Drug Approval*
Coronavirus Infections/*therapy
Pneumonia, Viral/*therapy
Humans ; Immunization, Passive ; Pandemics ; Plasma ; Politics ; Randomized Controlled Trials as Topic ; United States
SCR Disease Name :
COVID-19
Periodyk
Tytuł :
A dangerous rush for vaccines.
Autorzy :
Thorp HH; H. Holden Thorp Editor-in-Chief, Science journals. .
Pokaż więcej
Źródło :
Science (New York, N.Y.) [Science] 2020 Aug 21; Vol. 369 (6506), pp. 885. Date of Electronic Publication: 2020 Aug 13.
Typ publikacji :
Editorial
MeSH Terms :
Drug Approval*
Viral Vaccines*
Coronavirus Infections/*prevention & control
Pandemics/*prevention & control
Pneumonia, Viral/*prevention & control
Clinical Trials, Phase III as Topic ; Humans ; Randomized Controlled Trials as Topic ; Russia ; United States
SCR Disease Name :
COVID-19
Opinia redakcyjna
Tytuł :
Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned.
Autorzy :
Mashingia JH; East African Community Secretariat, Arusha, Tanzania.
Ahonkhai V; Gwynedd Consultancy, LLC, Philadelphia, Pennsylvania, United States of America.
Aineplan N; National Drug Authority, Kampala, Uganda.
Ambali A; African Union Development Agency-New Partnership for Africa's Development, Midrand, South Africa.
Angole A; National Drug Authority, Kampala, Uganda.
Arik M; Drug and Food Control Authority, Juba, South Sudan.
Azatyan S; World Health Organization, Geneva, Switzerland.
Baak P; Drug and Food Control Authority, Juba, South Sudan.
Bamenyekanye E; Directorate of Pharmacy, Medicines, and Laboratories, Bujumbura, Burundi.
Bizoza A; Rwanda Food & Drugs Authority, Kigali, Rwanda.
Chamdimba C; African Union Development Agency-New Partnership for Africa's Development, Midrand, South Africa.
Doerr P; Petra Doerr Consulting Ltd., Herznach, Switzerland.
Fimbo A; Tanzania Medicines and Medical Devices Authority, Dar Es Salaam, Tanzania.
Gisagara A; Rwanda Food & Drugs Authority, Kigali, Rwanda.
Hamad H; Zanzibar Food & Drug Agency, Zanzibar City, Zanzibar.
Harris R; Harris Access Consulting Ltd, London, United Kingdom.
Hartman D; Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.
Kabatende J; Rwanda Food & Drugs Authority, Kigali, Rwanda.
Karangwa C; Rwanda Food & Drugs Authority, Kigali, Rwanda.
Kijo AS; Tanzania Medicines and Medical Devices Authority, Dar Es Salaam, Tanzania.
Lumpkin M; Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.
Maboko S; Tanzania Medicines and Medical Devices Authority, Dar Es Salaam, Tanzania.
Matle D; Tanzania Medicines and Medical Devices Authority, Dar Es Salaam, Tanzania.
Muhairwe A; World Bank, Washington DC, United States of America.
Mwesigye JP; East African Community Secretariat, Arusha, Tanzania.
Nyabenda B; Directorate of Pharmacy, Medicines, and Laboratories, Bujumbura, Burundi.
Schulze A; Swiss Agency for Development and Cooperation, Bern, Switzerland.
Seiter A; World Bank, Washington DC, United States of America.
Sematiko G; National Drug Authority, Kampala, Uganda.
Sigonda M; African Union Development Agency-New Partnership for Africa's Development, Midrand, South Africa.
Sillo H; World Health Organization, Geneva, Switzerland.
Simai B; Zanzibar Food & Drug Agency, Zanzibar City, Zanzibar.
Siyoi F; Pharmacy & Poisons Board, Nairobi, Kenya.
Sonoiya S; East African Community Secretariat, Arusha, Tanzania.
Tanui P; African Union Development Agency-New Partnership for Africa's Development, Midrand, South Africa.
Ward M; World Health Organization, Geneva, Switzerland.
Yano F; Pharmacy & Poisons Board, Nairobi, Kenya.
Mukanga D; Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.
Pokaż więcej
Źródło :
PLoS medicine [PLoS Med] 2020 Aug 12; Vol. 17 (8), pp. e1003134. Date of Electronic Publication: 2020 Aug 12 (Print Publication: 2020).
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Review
MeSH Terms :
Drug Approval*/legislation & jurisprudence
Community Medicine/*trends
Drug and Narcotic Control/*trends
Health Services Accessibility/*trends
Africa, Eastern/epidemiology ; Community Medicine/legislation & jurisprudence ; Drug and Narcotic Control/legislation & jurisprudence ; Health Services Accessibility/legislation & jurisprudence ; Humans ; Time Factors
Czasopismo naukowe
Tytuł :
Post-approval Safety Monitoring of Quadrivalent and Bivalent Human Papillomavirus Vaccines Based on Real-world Data from the Korea Adverse Events Reporting System (KAERS).
Autorzy :
Kim M; School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon, Gyeonggi-do, 16419, South Korea.
Kim S; School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon, Gyeonggi-do, 16419, South Korea.
Shin JY; School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon, Gyeonggi-do, 16419, South Korea. .
Pokaż więcej
Źródło :
Clinical drug investigation [Clin Drug Investig] 2020 Aug; Vol. 40 (8), pp. 727-735.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Product Surveillance, Postmarketing*
Papillomavirus Infections/*prevention & control
Papillomavirus Vaccines/*therapeutic use
Adolescent ; Adult ; Algorithms ; Female ; Humans ; Papillomavirus Vaccines/adverse effects ; Papillomavirus Vaccines/immunology ; Republic of Korea
Czasopismo naukowe
Tytuł :
Adverse Consequences of Rushing a SARS-CoV-2 Vaccine: Implications for Public Trust.
Autorzy :
Trogen B; NYU Langone Health, New York, New York.
Oshinsky D; NYU Langone Health, New York, New York.
Caplan A; NYU Langone Health, New York, New York.
Pokaż więcej
Źródło :
JAMA [JAMA] 2020 Jun 23; Vol. 323 (24), pp. 2460-2461.
Typ publikacji :
Historical Article; Journal Article
MeSH Terms :
Betacoronavirus*
Drug Approval*
Patient Acceptance of Health Care*
Viral Vaccines*/adverse effects
Coronavirus Infections/*prevention & control
Immunization Programs/*organization & administration
Pandemics/*prevention & control
Pneumonia, Viral/*prevention & control
Drug Industry/history ; Health Communication/methods ; History, 20th Century ; Humans ; Poliovirus Vaccine, Inactivated/adverse effects ; Poliovirus Vaccine, Inactivated/history ; Safety/standards ; Trust ; United States ; Vaccination Refusal
SCR Disease Name :
COVID-19
Czasopismo naukowe
Tytuł :
Regulating drugs, medical devices, and diagnostic tests in the European Union: early lessons from the COVID-19 pandemic?
Autorzy :
Fraser AG; Department of Cardiology, University Hospital of Wales, Cardiff, UK.; Cardiovascular Imaging and Dynamics, Katholieke Universiteit Leuven Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
Szymański P; Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, ul. Woloska 137, 02-507 Warsaw, Poland.
Macintyre E; Hématologie Biologique and INSERM UMR1151, Université de Paris (Descartes), Hôpital Necker Enfants Malades, 149 rue de Sèvres, Paris 75743, France.
Landray M; Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK.
Pokaż więcej
Źródło :
European heart journal [Eur Heart J] 2020 Jun 14; Vol. 41 (23), pp. 2140-2144.
Typ publikacji :
Journal Article
MeSH Terms :
Device Approval*
Diagnostic Test Approval*
Drug Approval*
European Union*
Coronavirus Infections/*diagnosis
Coronavirus Infections/*therapy
Pneumonia, Viral/*diagnosis
Pneumonia, Viral/*therapy
Anti-Bacterial Agents ; Antibodies, Monoclonal, Humanized/therapeutic use ; Anticoagulants/therapeutic use ; Antimalarials/therapeutic use ; Antiviral Agents/therapeutic use ; Azithromycin/therapeutic use ; Betacoronavirus ; Biomedical Research ; Clinical Laboratory Techniques/standards ; Coronavirus Infections/drug therapy ; Coronavirus Infections/epidemiology ; Data Accuracy ; Drug and Narcotic Control ; Glucocorticoids/therapeutic use ; Heparin/therapeutic use ; Humans ; Immunization, Passive/standards ; Medical Device Legislation ; Pandemics ; Personal Protective Equipment/standards ; Pneumonia, Viral/epidemiology ; Ventilators, Mechanical/standards
SCR Disease Name :
COVID-19
Czasopismo naukowe
Tytuł :
Drug Evaluation during the Covid-19 Pandemic.
Autorzy :
Rome BN; From the 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.
Avorn J; From the 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.
Pokaż więcej
Źródło :
The New England journal of medicine [N Engl J Med] 2020 Jun 11; Vol. 382 (24), pp. 2282-2284. Date of Electronic Publication: 2020 Apr 14.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Coronavirus Infections/*drug therapy
Drug Evaluation/*standards
Pneumonia, Viral/*drug therapy
Betacoronavirus ; Chloroquine/supply & distribution ; Chloroquine/therapeutic use ; Clinical Trials as Topic ; Drugs, Investigational/therapeutic use ; Humans ; Hydroxychloroquine/supply & distribution ; Hydroxychloroquine/therapeutic use ; Off-Label Use ; Pandemics ; United States ; United States Food and Drug Administration
SCR Disease Name :
COVID-19
Czasopismo naukowe
Tytuł :
New Drugs Approved in 2019.
Autorzy :
Ebied AM; Department of Clinical Sciences, High Point University Fred Wilson School of Pharmacy, High Point, NC.
Patel KH; Department of Pharmacy, Vidant Medical Center, Greenville, NC.
Cooper-DeHoff RM; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, Fla. Electronic address: .
Pokaż więcej
Źródło :
The American journal of medicine [Am J Med] 2020 Jun; Vol. 133 (6), pp. 675-678. Date of Electronic Publication: 2020 Mar 05.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*
Prescription Drugs/*therapeutic use
Humans ; Prescription Drugs/administration & dosage ; Prescription Drugs/adverse effects ; United States ; United States Food and Drug Administration
Czasopismo naukowe

Ta witryna wykorzystuje pliki cookies do przechowywania informacji na Twoim komputerze. Pliki cookies stosujemy w celu świadczenia usług na najwyższym poziomie, w tym w sposób dostosowany do indywidualnych potrzeb. Korzystanie z witryny bez zmiany ustawień dotyczących cookies oznacza, że będą one zamieszczane w Twoim komputerze. W każdym momencie możesz dokonać zmiany ustawień dotyczących cookies