Congratulations to Jithesh Veetil, PhD, awarded The CDRH Regulatory Science Excellence Award for for the External Evidence Methods (EEM) Framework Project. MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical […]
Stakeholders seek tweaks to FDA’s voluntary improvement program guidance Regulatory NewsRegulatory News | 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to […]
LA JOLLA, Calif.–(BUSINESS WIRE)– Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, is pleased to announce that City of Hope has received U.S. Food and Drug Administration (FDA) authorization to proceed with a phase 1 physician-sponsored clinical trial that will use Calidi’s licensed oncolytic […]
https://live-mdic.pantheonsite.io/wp-content/uploads/2023/09/MDIC-logo_stacked.png00Matthew Victoriahttps://live-mdic.pantheonsite.io/wp-content/uploads/2023/09/MDIC-logo_stacked.pngMatthew Victoria2022-08-02 10:47:592022-08-02 14:20:59Around the Web: Calidi Biotherapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of NeuroNova in Patients with Recurrent High-Grade Glioma
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External Evidence Methods Framework Project earns CDRH Regulatory Science Excellence Award
Congratulations to Jithesh Veetil, PhD, awarded The CDRH Regulatory Science Excellence Award for for the External Evidence Methods (EEM) Framework Project. MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical […]
Around the Web: Stakeholders seek tweaks to FDA’s voluntary improvement program guidance
Stakeholders seek tweaks to FDA’s voluntary improvement program guidance Regulatory NewsRegulatory News | 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to […]
Around the Web: Calidi Biotherapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of NeuroNova in Patients with Recurrent High-Grade Glioma
LA JOLLA, Calif.–(BUSINESS WIRE)– Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, is pleased to announce that City of Hope has received U.S. Food and Drug Administration (FDA) authorization to proceed with a phase 1 physician-sponsored clinical trial that will use Calidi’s licensed oncolytic […]