martedì, 5 maggio 2026

Notizie AIOM – anno XVII

EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers

July 12, 2019 - With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in ...
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12 luglio 2019 – Comunicazione EMA su medicinali a base di ciproterone

12 luglio 2019 – Comunicazione EMA su metotrexato

12 luglio 2019 – Uso dei farmaci in Italia: AIFA presenta il Rapporto Nazionale 2018

13 luglio 2019 – Farmaci falsificati: AIFA, in Italia nessuna segnalazione

FDA Grants Durvalumab Orphan Drug Status in Small Cell Lung Cancer

July 12, 2019 - The FDA has granted an Orphan Drug Designation to durvalumab for the treatment of patients with small cell lung cancer (SCLC), according to AstraZeneca, the developer of the PD-L1 inhibitor. The designation follows the announcement of the phase III CASPIAN ...
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Medicaid Patients Need Clinical Trial Access, Coalition Tells Congress

July 10, 2019 - Today, organizations representing patients, providers, medical researchers, survivors, and their families joined together to call on Congress to improve access to clinical trials for patients with life-threatening diseases. The coalition, which is made up ...
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FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

July 9, 2019 - The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions. The new dosage would be applicable for the PD-1 inhibitor’s ...
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FDA Grants Fast Track Designation to CLR 131 for DLBCL

July 11, 2019 - The FDA has granted a fast track designation to CLR 131 for use as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The designation is based on findings from a DLBCL cohort that is part of the ongoing phase II CLOVER-1 ...
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Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities (ICMRA)

July 8, 2019 - The International Coalition of Medicines Regulatory Authorities (ICMRA) has elected EMA’s Executive Director Guido Rasi as its new chair. ICMRA brings together the leaders of regulatory authorities around the world to provide strategic directions for ...
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