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Home » Topics » Regulatory

Regulatory
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ODAC to ponder fitness of trial data solely from China

Feb. 8, 2022
By Mari Serebrov
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.
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Regulatory actions for Feb. 8, 2022

Feb. 8, 2022
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.
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FDA announces four new class II device designations

Feb. 7, 2022
By Mark McCarty
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.
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Regulators churn out guidance for drug sponsors

Feb. 7, 2022
By Mari Serebrov
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agency has released draft guidances on antibody-drug conjugates and immunogenicity information in labeling, revised a draft guidance on assessing pressor effects of drugs and finalized a guidance on population pharmacokinetics.
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Regulatory actions for Feb. 7, 2022

Feb. 7, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Karl Storz, Photocure, Qiagen.
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Being proactive could cut US FDA FOIA load

Feb. 7, 2022
By Mari Serebrov
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.
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Regulatory actions for Feb. 7, 2022

Feb. 7, 2022
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.
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US FDA OKs Sanofi’s sutimlimab after initial rejection

Feb. 7, 2022
By Richard Staines
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.
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EU flags in front of the Berlaymont building

Postmarket performance follow-up a key consideration in MDCG guidance for IVDs

Feb. 4, 2022
By Mark McCarty
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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Regulatory actions for Feb. 4, 2022

Feb. 4, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambu.
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