Biologicals En

Fiche du sujet

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Identifiant

Synonyme

Biologics

Discipline

Histoire, Philosophie et Sociologie des sciences (15) Economies et finances (15) Gestion et management (13) Droit (13) Histoire (10) Architecture, aménagement de l'espace (10) Archéologie et Préhistoire (10) Psychologie (2) Sociologie (1) Science politique (1) Sciences de l'information et de la communication (1)

Type de document

Articles (32) Billets de blog (16) Livres et chapitres d'ouvrages (14) Recensions (9) Autres (9) Mémoires, Thèses et HDR (3) Colloques et conférences (1)

Auteur

Date

66 documents
USA – FDA finalizes guidance on real-world evidence in drug approvals
vroby (12 mars 2024)
EMA - New page dedicated to Q&A on biological medicinal products
vroby (11 mars 2024)
European Directorate for the Quality of Medicines (EDQM) - Joint USP-EDQM Symposium on "Pharmaceutical Reference Standards" (Catapult's regulatory round-up - June)
adelage (21 févr. 2024)
USA FDA - OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products (Catapult's regulatory round-up - July)
adelage (21 févr. 2024)
FDA outlines risk-based approach to monitoring clinical trials (Catapult's regulatory round-up - April)
adelage (19 févr. 2024)
FDA - OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls in April 2023 (Catapult's regulatory round-up - March)
adelage (19 févr. 2024)
FDA - Clinical Trials: The Patient Experience (Catapult's regulatory round-up - March)
adelage (19 févr. 2024)
FDA - Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products (Catapult's regulatory round-up - March)
adelage (19 févr. 2024)
Le titre du document n'a pas été fourni à ISIDORE, pour consulter le document, cliquez ici
(8 janv. 2024)
Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products - Catapult's regulatory round-up
adelage (22 déc. 2023)
Le titre du document n'a pas été fourni à ISIDORE, pour consulter le document, cliquez ici
(1 déc. 2023)
EMA - Work plan for the Biologics Working Party (BWP) for 2023
vroby (4 mai 2023)
Le titre du document n'a pas été fourni à ISIDORE, pour consulter le document, cliquez ici
(2 févr. 2023)
FDA - Human Gene Therapy for Neurodegenerative Diseases Guidance for Industry (Cell and Gene Therapy Catapult - Regulatory Round-up – October 2022)
adelage (25 janv. 2023)
FDA - OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls (Cell and Gene Therapy Catapult - Regulatory Round-up – October 2022)
adelage (25 janv. 2023)
Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products (Cell and Gene Therapy Catapult - Regulatory Round-up – November 2022)
adelage (25 janv. 2023)
FDA OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – Transcript now available (Cell and Gene Therapy Catapult - Regulatory Round-up – November 2022)
adelage (25 janv. 2023)
Retrospectives on Three Decades of Safe Clinical Experience with Allogeneic Dermal Progenitor Fibroblasts: High Versatility in Topical Cytotherapeutic Care.
A. Laurent et al. (4 janv. 2023)
Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis
Andrea Chiricozzi et al. (2023)
Psoriasis care during the time of COVID-19: real-world data on changes in treatments and appointments from a German university hospital
Nadia Ninosu et al. (2023)
Safety of biologics for psoriasis patients during the COVID-19 pandemic: the experience from Wuhan, China
Liang Zhao et al. (2023)
Treatment of pityriasis rubra pilaris: a case series of 28 patients
Christian Kromer et al. (2023)
Clinical characteristics of psoriatic patients with latent tuberculosis infection
Min Seok Hur et al. (2023)
Treatment of pityriasis rubra pilaris type I: a systematic review
Carina Engelmann et al. (2023)
Prevalence of HPV genital infection in patients with moderate-to-severe psoriasis undergoing systemic treatment with immunosuppressive agents or biologics
Annamaria Offidani et al. (2023)

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