Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atheart Medical, Carestream, Cerevasc.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Azurity, Biogen, Celltrion, Everest, Gilead, GW, Jazz, NGM, Obseva, RDIF, Sanofi, Sinomab.
The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.
The U.S. FDA appears to be on a roll when it comes to rolling out new guidance pertaining to prescription drugs. In recent days, the agency has released draft guidances on antibody-drug conjugates and immunogenicity information in labeling, revised a draft guidance on assessing pressor effects of drugs and finalized a guidance on population pharmacokinetics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Karl Storz, Photocure, Qiagen.
As the U.S. FDA struggles to meet a massive court-ordered release of documents related to its approval of the Pfizer Inc.-Biontech SE COVID-19 vaccine, it could help itself by being more proactive in publicly releasing documents related to the approval and labeling of prescription drugs, according to a U.S. regulatory expert.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytokinetics, Mylan Laboratories, Novavax, RDIF, Revolo, Roche, TG, Tiziana, Viatris.
The U.S. FDA has approved Sanofi SA’s treatment for cold agglutinin disease (CAD), sutimlimab, after the drug was initially rejected by the regulator for technical reasons in 2020. Paris-based Sanofi’s drug will be branded as Enjaymo.
The guidances for in vitro diagnostics (IVDs) developed by the European Union’s Medical Device Coordination Group (MDCG) are only a reflection of the In Vitro Diagnostic Regulation (IVDR), but they do provide test developers with some important details.
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