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Wyświetlanie 1-20 z 10666
Tytuł:
Lessons from CDER's Quality Management Maturity Pilot Programs.
Autorzy:
Maguire J; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA. .
Fisher A; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Harouaka D; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Rakala N; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Lundi C; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Yambot M; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Viehmann A; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Stiber N; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Gonzalez K; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Canida L; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Buhse L; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
Kopcha M; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
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Źródło:
The AAPS journal [AAPS J] 2023 Jan 10; Vol. 25 (1), pp. 14. Date of Electronic Publication: 2023 Jan 10.
Typ publikacji:
Journal Article
MeSH Terms:
United States Food and Drug Administration*
United States ; Drug Evaluation
Czasopismo naukowe
Szczegóły
Tytuł:
FDA approves Alzheimer's drug lecanemab amid safety concerns.
Autorzy:
Reardon S
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Źródło:
Nature [Nature] 2023 Jan; Vol. 613 (7943), pp. 227-228.
Typ publikacji:
News; Comment
MeSH Terms:
Alzheimer Disease*/drug therapy
United States Food and Drug Administration*/legislation & jurisprudence
Patient Safety*
Antibodies, Monoclonal, Humanized*/adverse effects
Antibodies, Monoclonal, Humanized*/therapeutic use
Drug Approval*
Humans ; United States
Periodyk
Szczegóły
Tytuł:
Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan.
Autorzy:
Ono M; Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, Waseda University, 2-2 Wakamatsucho, Shinjuku, Tokyo, 162-8480, Japan.
Iwasaki K; Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, Waseda University, 2-2 Wakamatsucho, Shinjuku, Tokyo, 162-8480, Japan. .; Department of Modern Mechanical Engineering, School of Creative Science and Engineering, Waseda University, Tokyo, 169-8555, Japan. .; Department of Integrative Bioscience and Biomedical Engineering, Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, 162-8480, Japan. .; Institute for Medical Regulatory Science, Waseda University, Tokyo, 162-8480, Japan. .
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Źródło:
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Jan; Vol. 57 (1), pp. 86-99. Date of Electronic Publication: 2022 Sep 07.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
United States Food and Drug Administration*
United States ; Japan
Czasopismo naukowe
Szczegóły
Tytuł:
A Survey of Population Pharmacokinetic Reports Submitted to the USFDA: An Analysis of Common Issues in NDA and BLA from 2012 to 2021.
Autorzy:
Hsu LF; Department of Pharmacy, School of Pharmaceutical Sciences, National Yang Ming Chiao Tung University, Taipei, Taiwan. .; Center for Drug Evaluation (CDE), 3F, No. 465, Sec. 6, Zhongxiao E. Rd., Taipei, 11557, Taiwan. .
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Źródło:
Clinical pharmacokinetics [Clin Pharmacokinet] 2022 Dec; Vol. 61 (12), pp. 1697-1703. Date of Electronic Publication: 2022 Oct 31.
Typ publikacji:
Journal Article
MeSH Terms:
United States Food and Drug Administration*
United States ; Humans
Czasopismo naukowe
Szczegóły
Tytuł:
Regulating Between the Notes: The US FDA and the Evolution of the Patient Voice Through Twenty-First Century Regulatory Science.
Autorzy:
Pitts PJ; Center for Medicine in the Public Interest, 757 Third Avenue, New York, NY, 10017, USA. .
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Źródło:
The patient [Patient] 2022 Nov; Vol. 15 (6), pp. 611-613. Date of Electronic Publication: 2022 Sep 20.
Typ publikacji:
Journal Article
MeSH Terms:
United States Food and Drug Administration*
Patient Advocacy*
Humans ; United States
Czasopismo naukowe
Szczegóły
Tytuł:
Regulatory insight from low-income countries.
Autorzy:
Mukonzo JK; Department of Pharmacology & Therapeutics, Makerere University, College of Health Science, Uganda.
Price DA; DebateGraph, Somerset, UK.
Grasela TH; School of Pharmacy, University at Buffalo, Buffalo, NY 14260, USA.; Azimuth Global Health Consulting, LLC, Amherst, NY 14226, USA.
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Źródło:
Science (New York, N.Y.) [Science] 2022 Oct 21; Vol. 378 (6617), pp. 256. Date of Electronic Publication: 2022 Oct 20.
Typ publikacji:
Letter; Comment
MeSH Terms:
Developing Countries*
Poverty*
Information Dissemination*
United States Food and Drug Administration*
Income
Opinia redakcyjna
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Interview with Dr William Slikker Jr., Ph.D., Former Director, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), USA.
Autorzy:
Dobran SA; RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania.; Sociology Department, Babes-Bolyai University, Cluj-Napoca, Romania.
Gherman A; RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania.
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Źródło:
Journal of medicine and life [J Med Life] 2022 Oct; Vol. 15 (10), pp. 1207-1208.
Typ publikacji:
Interview
MeSH Terms:
United States Food and Drug Administration*
Toxicology*
Humans ; United States
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Transparency practices at the FDA: A barrier to global health.
Autorzy:
Lumpkin MM; Bill & Melinda Gates Foundation, Seattle, WA, USA.
Hamburg MA; Independent researcher, Washington, DC, USA.
Schultz WB; Zuckerman Spaeder, Washington, DC, USA.
Sharfstein JM; Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21209, USA.
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Źródło:
Science (New York, N.Y.) [Science] 2022 Aug 05; Vol. 377 (6606), pp. 572-574. Date of Electronic Publication: 2022 Aug 04.
Typ publikacji:
Journal Article
MeSH Terms:
Global Health*
Information Dissemination*
United States Food and Drug Administration*
United States
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Adverse Events Following Transcatheter Edge-to-Edge Repair (TEER) Using MitraClip: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Registry.
Autorzy:
Dodoo SN; Department of Internal Medicine, Piedmont Newnan Hospital, United States of America. Electronic address: .
Okoh AK; Division of Cardiology, Department of Medicine, Emory University School of Medicine, United States of America.
Oseni A; Division of Cardiology, Department of Medicine, Oklahoma University College of Medicine, United States of America.
Odiete O; Peach-state Advanced Cardiac and Endovascular Center, Newnan, Georgia.
Okafor HE; Division of Cardiology, Department of Medicine, Vanderbilt University School of Medicine, United States of America.
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Źródło:
Cardiovascular revascularization medicine : including molecular interventions [Cardiovasc Revasc Med] 2022 Jun; Vol. 39, pp. 101-105. Date of Electronic Publication: 2021 Sep 30.
Typ publikacji:
Journal Article
MeSH Terms:
United States Food and Drug Administration*
Databases, Factual ; Humans ; Registries ; United States
Czasopismo naukowe
Szczegóły
Tytuł:
Evaluating the evaluators - Developing evidence of quality oversight effectiveness for clinical trial monitoring: Source data verification, source data review, statistical monitoring, key risk indicators, and direct measure of high risk errors.
Autorzy:
Manasco P; MANA RBM, United States of America. Electronic address: .
Bhatt DL; Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis Street, Boston, MA 02115, United States of America. Electronic address: .
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Źródło:
Contemporary clinical trials [Contemp Clin Trials] 2022 Jun; Vol. 117, pp. 106764. Date of Electronic Publication: 2022 Apr 15.
Typ publikacji:
Journal Article
MeSH Terms:
United States Food and Drug Administration*
Humans ; Risk Factors ; United States
Czasopismo naukowe
Szczegóły
Tytuł:
Inclusion of women in FDA-regulated premarket clinical trials: A call for innovative and recommended action.
Autorzy:
Samaei M; Division of Sex and Gender in Emergency Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.
McGregor AJ; Division of Sex and Gender in Emergency Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.
Jenkins MR; University of South Carolina School of Medicine Greenville Campus, Greenville, SC, USA. Electronic address: .
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Źródło:
Contemporary clinical trials [Contemp Clin Trials] 2022 May; Vol. 116, pp. 106708. Date of Electronic Publication: 2022 Feb 16.
Typ publikacji:
Journal Article; Review
MeSH Terms:
Clinical Trials as Topic*
United States Food and Drug Administration*
Drug Approval ; Female ; Humans ; Male ; United States
Czasopismo naukowe
Szczegóły
Tytuł:
FDA Indication Extrapolations-Allowing Flexibility While Providing Greater Clarity.
Autorzy:
Ramachandran R; National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Veterans Affairs Connecticut Healthcare System and Yale University, West Haven, Connecticut.
Ross JS; National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut.
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Źródło:
JAMA network open [JAMA Netw Open] 2022 Apr 01; Vol. 5 (4), pp. e227961. Date of Electronic Publication: 2022 Apr 01.
Typ publikacji:
Journal Article; Comment
MeSH Terms:
United States Food and Drug Administration*
Humans ; United States
Czasopismo naukowe
Szczegóły
Tytuł:
The Food and Drug Administration's (FDA's) Drug Safety Surveillance During the COVID-19 Pandemic.
Autorzy:
Diak IL; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. .
Swank K; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
McCartan K; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Beganovic M; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Kidd J; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Gada N; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Kapoor R; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Wolf L; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Kangas L; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Wyeth J; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Salvatore T; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Fanari M; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
LeBoeuf AA; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Mishra P; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Blum MD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Dal Pan G; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
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Źródło:
Drug safety [Drug Saf] 2023 Feb; Vol. 46 (2), pp. 145-155. Date of Electronic Publication: 2022 Dec 02.
Typ publikacji:
Journal Article
MeSH Terms:
COVID-19*
Poisons*
Humans ; United States/epidemiology ; Pharmaceutical Preparations ; Pandemics ; United States Food and Drug Administration ; Pharmacovigilance
Czasopismo naukowe
Szczegóły
Tytuł:
Cardiovascular toxicities with pediatric tyrosine kinase inhibitor therapy: An analysis of adverse events reported to the Food and Drug Administration.
Autorzy:
Narayan HK; Department of Pediatrics, University of California San Diego, La Jolla, California, USA.
Sheline K; Department of Pediatrics, University of California San Diego, La Jolla, California, USA.
Wong V; Department of Pediatrics, University of California San Diego, La Jolla, California, USA.
Kuo D; Department of Pediatrics, University of California San Diego, La Jolla, California, USA.
Choo S; Department of Pediatrics, University of California San Diego, La Jolla, California, USA.
Yoon J; Department of Pediatrics, City of Hope, Duarte, California, USA.
Leger K; Department of Pediatrics, University of Washington, Seattle, Washington, USA.
Kutty S; Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland, USA.
Fradley M; Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Tremoulet A; Department of Pediatrics, University of California San Diego, La Jolla, California, USA.
Ky B; Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Armenian S; Department of Pediatrics, City of Hope, Duarte, California, USA.
Guha A; Cardio-Oncology Program, Georgia Cancer Center, Medical College of Georgia at Augusta University, Augusta, Georgia, USA.; Division of Cardiology, Department of Medicine, Medical College of Georgia at Augusta University, Augusta, Georgia, USA.
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Źródło:
Pediatric blood & cancer [Pediatr Blood Cancer] 2023 Feb; Vol. 70 (2), pp. e30059. Date of Electronic Publication: 2022 Nov 17.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural
MeSH Terms:
Heart Failure*/chemically induced
Hypertension*
Antineoplastic Agents*/adverse effects
United States ; Humans ; Child ; Sorafenib/adverse effects ; Tyrosine Protein Kinase Inhibitors ; United States Food and Drug Administration ; Protein Kinase Inhibitors/adverse effects
Czasopismo naukowe
Szczegóły
Tytuł:
Cardiovascular complications of modern multiple myeloma therapy: A pharmacovigilance study.
Autorzy:
Al-Yafeai Z; Department of Internal Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, LA, USA.
Ghoweba M; Department of Internal Medicine, CHRISTUS Good Shepherd/Texas A&M College of Medicine, Longview, TX, USA.
Ananthaneni A; Department of Internal Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, LA, USA.
Abduljabar H; Department of Internal Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, LA, USA.
Aziz D; Department of Internal Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, LA, USA.
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Źródło:
British journal of clinical pharmacology [Br J Clin Pharmacol] 2023 Feb; Vol. 89 (2), pp. 641-648. Date of Electronic Publication: 2022 Sep 09.
Typ publikacji:
Review; Journal Article
MeSH Terms:
Multiple Myeloma*/drug therapy
Humans ; United States ; Pharmacovigilance ; Cardiotoxicity/epidemiology ; Cardiotoxicity/etiology ; Panobinostat/therapeutic use ; Adverse Drug Reaction Reporting Systems ; United States Food and Drug Administration
Czasopismo naukowe
Szczegóły
Tytuł:
Trends in copper versus hormonal intrauterine device breakage reporting within the United States' Food and Drug Administration Adverse Event Reporting System.
Autorzy:
Latack KR; Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United States. Electronic address: .
Nguyen BT; Department of Obstetrics and Gynecology, Section of Family Planning, University of Southern California, Los Angeles, CA, United States.
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Źródło:
Contraception [Contraception] 2023 Feb; Vol. 118, pp. 109909. Date of Electronic Publication: 2022 Oct 31.
Typ publikacji:
Journal Article
MeSH Terms:
Intrauterine Devices, Medicated*/adverse effects
Intrauterine Devices, Copper*/adverse effects
Intrauterine Devices*/adverse effects
United States ; Female ; Humans ; Copper ; United States Food and Drug Administration
Czasopismo naukowe
Szczegóły
Tytuł:
Trends in clinical validation and usage of US Food and Drug Administration-cleared artificial intelligence algorithms for medical imaging.
Autorzy:
Khunte M; Warren Alpert School of Medicine, Brown University, Providence, RI, USA.
Chae A; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Wang R; Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jain R; Brown University, Providence, RI, USA.
Sun Y; The World Bank, Washington D.C.,DC, USA.
Sollee JR; Warren Alpert School of Medicine, Brown University, Providence, RI, USA.
Jiao Z; Department of Diagnostic Imaging, Warren Alpert School of Medicine, Brown University, Providence, RI, USA.
Bai HX; Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: .
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Źródło:
Clinical radiology [Clin Radiol] 2023 Feb; Vol. 78 (2), pp. 123-129. Date of Electronic Publication: 2022 Oct 28.
Typ publikacji:
Journal Article
MeSH Terms:
Artificial Intelligence*
Algorithms*
United States ; Humans ; Retrospective Studies ; United States Food and Drug Administration ; Diagnostic Imaging
Czasopismo naukowe
Szczegóły
Tytuł:
Analysis of adverse event of interstitial lung disease in men with prostate cancer receiving hormone therapy using the Food and Drug Administration Adverse Event Reporting System.
Autorzy:
Wu B; Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Shen P; Department of Urology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Yin X; Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Yu L; Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Wu F; Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Chen C; West China School of Pharmacy, Sichuan University, Chengdu, Sichuan, China.
Li J; Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Xu T; Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.; West China School of Pharmacy, Sichuan University, Chengdu, Sichuan, China.
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Źródło:
British journal of clinical pharmacology [Br J Clin Pharmacol] 2023 Feb; Vol. 89 (2), pp. 440-448. Date of Electronic Publication: 2022 Apr 07.
Typ publikacji:
Journal Article
MeSH Terms:
Lung Diseases, Interstitial*/chemically induced
Lung Diseases, Interstitial*/epidemiology
Prostatic Neoplasms*/drug therapy
Antineoplastic Agents, Hormonal*/adverse effects
Antineoplastic Agents, Hormonal*/therapeutic use
Androgen Antagonists*/adverse effects
Androgen Antagonists*/therapeutic use
Humans ; Male ; Adverse Drug Reaction Reporting Systems ; Flutamide/therapeutic use ; Goserelin/adverse effects ; United States/epidemiology ; United States Food and Drug Administration
Czasopismo naukowe
Szczegóły
Wyświetlanie 1-20 z 10666

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