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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
The Committee for Advanced Therapies (CAT) was established in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (ATMPs) such as gene therapy, somatic cell therapy and tissue engineered products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in the field.
Expert Opinion on Biological Therapy is a monthly peer-reviewed medical journal covering research on all aspects of biological therapy, including gene therapy and gene transfer technologies, therapeutic peptides and proteins, vaccines and antibodies, and cell- and tissue-based therapies.
Current Gene Therapy is a peer-reviewed medical journal published by Bentham ... the 2022-2023 journal impact factor is 4.676 and the real-time impact factor is 5.7. [7]
Talimogene laherparepvec is delivered by injecting it directly into tumors, thereby creating a systemic anti-tumor immune response. [2]In the US, talimogene laherparepvec is FDA approved to treat Stage IIIb-IVM1c melanoma patients for whom surgical intervention is not appropriate and with tumors which can be directly injected; the EMA approved population in Europe is for Stage IIIb-IVM1a.
One such example is Nusinersen (Spinaraza), it functions as an ASO and targets pre-mRNA before splicing that corresponds to Survival of motor neuron 2 gene (SMN 2). [34] This drug therapy was approved by FDA and EMA in 2016 and 2017 respectively. There are some drugs that have been approved by FDA and not by EMA.
Errors related to medication use, lack of documentation on how medicines are prescribed, used and dispensed, as well as insufficient communication have a considerable impact on national mortality and morbidity rates. Therefore, the safe and appropriate use of medicines, which depends on the right information being available to those that need ...
Cambiogenplasmid (Neovasculgen): treatment for vascular endothelial growth factor peripheral artery disease; Ciltacabtagene autoleucel (Carvykti): treatment for multiple myeloma [6] Delandistrogene moxeparvovec (Elevidys): treatment for Duchenne muscular dystrophy [7] [8] Elivaldogene autotemcel (Skysona): treatment for cerebral ...