المؤلفون: Ayalew K; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA. Kassa.Ayalew@fda.hhs.gov.; U.S. Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5370, Silver Spring, MD, 20993, USA. Kassa.Ayalew@fda.hhs.gov., Ning YM; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA., Foringer MJ; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA., Leibenhaut S; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA., Sellers JW; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA., Yu B; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA., Kronstein PD; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA., Higgerson A; Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands., Mihaescu C; Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands., Rodriguez M; Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands., Williams L; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA., Khin NA; Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Jan; Vol. 57 (1), pp. 79-85. Date of Electronic Publication: 2022 Aug 16.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Marketing*, Humans ; United States ; United States Food and Drug Administration ; Europe

المؤلفون: Ghadanian M; Division of Pharmacy & Optometry, Faculty of Biology, Medicine & Health, School of Health Sciences, The University of Manchester, Manchester, UK., Schafheutle E; Division of Pharmacy & Optometry, Faculty of Biology, Medicine & Health, School of Health Sciences, The University of Manchester, Manchester, UK. ellen.schafheutle@manchester.ac.uk.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Jan; Vol. 58 (1), pp. 79-113. Date of Electronic Publication: 2023 Oct 20.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: COVID-19 Vaccines* , COVID-19*, United States ; Humans ; United States Food and Drug Administration ; Pandemics ; Drug Approval ; Pharmaceutical Preparations ; Marketing

المؤلفون: Izem R; Statistical Methodology and Consulting, Novartis, Basel, Switzerland., Buenconsejo J; Biometrics, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, 101 Orchard Ridge Dr., Gaithersburg, MD, 20878, USA. jbsinfuego@yahoo.com., Davi R; Data Science, Acorn AI, Medidata, New York, NY, USA., Luan JJ; Regulatory Affairs, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA., Tracy L; Medical and RWD Analytics, Otsuka Pharmaceutical Development and Commercialization, Inc., Princeton, NJ, USA., Gamalo M; Global Biometrics and Data Management, Inflammation and Immunology Statistics, Pfizer, Collegeville, PA, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2022 Sep; Vol. 56 (5), pp. 704-716. Date of Electronic Publication: 2022 Jun 08.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Biological Products* , Marketing*, Data Collection/methods ; Humans

المؤلفون: Hearns-Stewart RM; Integrated Review of Marketing Applications, Office of New Drugs Special Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. rhonda.hearns-stewart@fda.hhs.gov., Farley J; Director, Office of Infectious Disease, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Lee KJ; Office of New Drug Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Connelly S; Office of Infectious Disease, Division of Antivirals, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Lowy N; Division of Anesthesiology, Addiction Medicine and Pain Medicine, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Stein P; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Bugin K; Special Programs, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 May; Vol. 55 (3), pp. 467-472. Date of Electronic Publication: 2020 Nov 24.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Marketing* , Pharmaceutical Preparations*, United States ; United States Food and Drug Administration

المؤلفون: Raber-Johnson ML; College of Pharmacy, Division of Pharmacy Education and Innovation, The Ohio State University, Columbus, OH, USA. Johnson.6844@osu.edu., Stinson M; Bioscience Bridge, LLC, Boise, ID, USA., Dillon C; Dillon Consulting, LLC, Jupiter, FL, USA., Wan GJ; Health Economics and Outcomes Research, Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 Jul; Vol. 55 (4), pp. 696-704. Date of Electronic Publication: 2021 Mar 15.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Communication* , Marketing*, Health Personnel ; Humans

المؤلفون: Manko Singer W; Individual Case Medical Review, Global Clinical Safety & Pharmacovigilance, Merck, Sharp & Dohme, LLC, Rahway, NJ, USA. wendy.manko.singer@merck.com., Pileggi EM; Global Case and Safety Data Management, Global Medical Safety, Janssen, The Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA., Gibble Y; Pharmacovigilance Partner Strategy and Management, Global Clinical Safety & Pharmacovigilance, Merck Sharp & Dohme LLC, Rahway, NJ, USA., Lewis DJ; Global Drug Development, Novartis Pharma GmbH, Wehr, Germany.; School of Life and Medical Sciences, University of Hertfordshire, Hatfield, England.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Sep; Vol. 57 (5), pp. 1050-1061. Date of Electronic Publication: 2023 Jun 21.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Pharmacovigilance* , Negotiating*, Humans ; Patient Safety ; Marketing

المؤلفون: Kohama M; Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Nonaka T; Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Uyama Y; Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Ishiguro C; Section of Clinical Epidemiology, Department of Data Science, Center for Clinical Science, National Center for Global Health and Medicine, 1-21-1, Toyama Shinjuku-ku, Tokyo, 162-8655, Japan. chishiguro@hosp.ncgm.go.jp.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Jan; Vol. 57 (1), pp. 37-47. Date of Electronic Publication: 2022 Aug 13.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Pharmacovigilance* , Drug-Related Side Effects and Adverse Reactions*/prevention & control, Humans ; Risk Management/methods ; Databases, Factual ; Marketing

المؤلفون: Yuan J; Allergan Inc, 2525 Dupont Drive, MI2-2D, Irvine, CA, 92612, USA. jiacheng.yuan@allergan.com., Zhu R; Allergan Inc, 2525 Dupont Drive, MI2-2D, Irvine, CA, 92612, USA., Jia D; Allergan Inc, Madison, NJ, USA., Palm U; Allergan Inc, Madison, NJ, USA., Koch G; Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2020 May; Vol. 54 (3), pp. 571-576. Date of Electronic Publication: 2020 Jan 06.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Marketing*, Animals ; Humans

المؤلفون: Roberts SW; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. osrb@novonordisk.com., Elvang TLB; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Syed L; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Samuelsen MB; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Arp-Hansen EL; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Nielsen HK; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Lund IK; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Dünweber DL; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Listov-Saabye N; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Bjørn-Larsen D; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Hjelmsmark A; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark., Mikkelsen TA; Regulatory Affairs, Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Mar; Vol. 57 (2), pp. 386-395. Date of Electronic Publication: 2022 Nov 18.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Orphan Drug Production* , Drug Approval*, United States ; Humans ; European Union ; Rare Diseases/drug therapy ; Marketing

المؤلفون: Deavin A; GSK, 20 Avenue Fleming, 1300, Wavre, Belgium. andrew.x.deavin@gsk.com., Adam S; The International Federation of Pharmaceutical Manufacturers and Associations, Chemin des Mines 9, 1202, Geneva, Switzerland., Ausborn S; F. Hoffmann - La Roche Ltd, Grenzacher Strasse 124, 4070, Basel, Switzerland., Nielsen ASB; Novo Nordisk, Vandtaarnsvej 108, 2860, Soeborg, Denmark., Cappellini S; Menarini Ricerche S.p.A, Via Tito Speri 10, Pomezia, Rome, Italy., Colmagne-Poulard I; Merck KGaA, Chemin de l'Ouriettaz, 1170, Aubonne, Switzerland., Gastineau T; Sanofi, 14 Espace Henry Vallée, 69007, Lyon, France., Gonzalez-Martinez A; GSK, 20 Avenue Fleming, 1300, Wavre, Belgium., Meillerais S; MSD-Europe Inc., Clos du Lynx, 5, Lynx Binnenhof, 1200, Brussels, Belgium., Mortazavi C; Sanofi R&D, 1 Avenue Brossolette, 91385, Chilly Mazarin, France.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Jan; Vol. 57 (1), pp. 7-11. Date of Electronic Publication: 2022 Aug 02.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Change Management* , Vaccines*, Humans ; Europe ; Marketing ; Quality Control