Results 91 to 100 of about 7,238,985 (145)

Regulatory approach to manipulated organs in Europe: preserving human organs as non-commercial goods. [PDF]

Transpl Int
Cuende N, Izeta A, Domínguez-Gil B.
europepmc   +1 more source

Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU. [PDF]

Front Med (Lausanne)
Van Isterdael C, Mugarza E, Fischer P, Debackere K, Vandenberghe P, Martin Lluesma S, Van Eldere J, Huys I.   +7 more
europepmc   +1 more source

Advanced therapy medicinal product (ATMP) classification - a case study on spinal cord injury. [PDF]

J Transl Med
Duarte L, Castellà M, Marques PAAP, Gago B.   +3 more
europepmc   +1 more source

Regulatory Challenges and Opportunities for Cell-Derived Extracellular Vesicles in Pharmaceutical Development: A European and Global Perspective. [PDF]

J Extracell Vesicles
Limongi T, Milla P, Stella B, Arpicco S.
europepmc   +1 more source

Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets. [PDF]

BioTech (Basel)
Verma N, Arora S.
europepmc   +1 more source

Why promising ATMPs fail to reach patients: a qualitative stakeholder-informed analysis of cell therapy access in Europe. [PDF]

J Transl Med
Di Mauro G, Pachetti M, Ploner C, De Luca M, Pellegrini G, Gambini E, Moretti M, Sfiligoj A, Yordanov TE, Knezevic M, Sidoti GB, Papa G, Zacchigna S.   +12 more
europepmc   +1 more source

Most-Favored-Nation pricing meets Joint Clinical Assessment: early evidence of compounding pressure on European drug launches. [PDF]

J Comp Eff Res
Ramagopalan SV, Ryan ML.
europepmc   +1 more source

Rare disease clinical trials in Italy (2022-May 2026): current trends, future challenges, and the evolving role as reporting member state. [PDF]

Front Pharmacol
De Paola E, Galliccia F, Maione R, Verrelli NM, Dri DA.   +4 more
europepmc   +1 more source

Advances in cell therapy for solid tumours: European perspective and future directions. [PDF]

Lancet Reg Health Eur
Moreno V, Thistlethwaite F, Yarza R, Tak WS, Lim KHJ, Haanen JBAG.   +5 more
europepmc   +1 more source

Editorial: Clinical translation and commercialisation of advanced therapy medicinal products, volume II. [PDF]

Front Bioeng Biotechnol
Bayon Y, Vertès AA.
europepmc   +1 more source