Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Albireo, Arrowhead, Astrazeneca, Aurinia, Beigene, EMD Serono, Eusa, Iterum, Junshi, Pfizer, Waymade.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Antios, Astrazeneca, Durect, Dynavax, Exelixis, Genentech, Macrogenics, Medigen, Synairgen, Zydus.
The latest global regulatory news, changes and updates affecting biopharma, including: And now the state cases; Advamed urges administration to communicate on DPA; Looking for GCP volunteers.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed urges administration to communicate on DPA; FDA posts third-party report for Q1, FY 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Fluidigm.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alkido, Amarin, Aurinia, Biontech, Continuous, Edding, Eli Lilly, Esperion, Evgen, GSK, Humanigen, ICER, Innocan, Microba, Pfizer, Sartorius Stedim, Vaxess.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Birchbiomed, Immutep, Nanoform, Regeneron, Sanofi, Senhwa, Windtree.
The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime.
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