Results 41 to 50 of about 73,074 (112)

Evaluating Data Quality by Proxy: Can We Evaluate All Dimensions of the European Medicines Agency Data Quality Framework for Registry-Based Post-Authorization Safety Studies? [PDF]

Pharmacoepidemiol Drug Saf
Dobay P, Sabidó M.
europepmc   +1 more source

Reported hepatotoxicity and hepatotoxicity guidance in the product information of protein kinase inhibitors in oncology registered at the European Medicines Agency. [PDF]

Pharmacol Res Perspect, 2023
Maliepaard M, Faber YS, van Bussel MTJ.
europepmc   +1 more source

Evolution of the European Medicines Agency clinical guidelines for epilepsy drug development between 2010 and 2025: A comparative analysis by the ILAE Task Force on Regulatory Affairs. [PDF]

Epilepsia
Auvin S, Arzimanoglou A, French J, Knupp KG, Lagae L, Trinka E, Dlugos D, Perucca E.   +7 more
europepmc   +1 more source

The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer. [PDF]

ESMO Open, 2022
Michaleas S, Moreno Oliver A, Mueller-Berghaus J, Sarac SB, van der Elst ME, Müller-Egert S, Zander H, Enzmann H, Pignatti F.   +8 more
europepmc   +1 more source

Brexit and the European Medicines Agency—What Next for the Agency and UK Drug Regulators?

JAMA Health Forum, 2020
Wouters, O.J., Hervey, T., McKee, M.
openaire   +3 more sources

European Medicines Agency: leave the UK but remain the same [PDF]

Journal of the Royal Society of Medicine, 2016
Livio, Garattini, Alessandro, Curto
openaire   +2 more sources

Biomarkers for neurodegenerative diseases in regulatory decision-making by the European Medicines Agency. [PDF]

Alzheimers Dement (N Y)
Hermans AMM, Bakker E, Starokozhko V, den Otter L, Elferink AJA, Bradshaw A, Guizzaro L, Mol PGM, Pasmooij AMG.   +8 more
europepmc   +1 more source

A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration. [PDF]

Clin Transl Sci, 2023
Rohr UP, Iovino M, Rudofsky L, Li Q, Juritz S, Gircys A, Wildner O, Bujar M, Bolte C, Dalla Torre di Sanguinetto S, Wolfer A.   +10 more
europepmc   +1 more source

The impact of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to address shortages of human and veterinary medicines across Europe. [PDF]

Front Public Health
Abed I, Bennett V, Cuddy B, Dang S, García Burgos J, Di Giorgio D, Lamas M, Radulovic M, Simões N, Santos Ivo R, Malonne H, Dias M.   +11 more
europepmc   +1 more source

Biomarker and Companion Diagnostics-A Review of Medicinal Products Approved by the European Medicines Agency. [PDF]

Front Med (Lausanne), 2021
Orellana García LP, Ehmann F, Hines PA, Ritzhaupt A, Brand A.   +4 more
europepmc   +1 more source