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  2. JANUS clinical trial data repository - Wikipedia

    en.wikipedia.org/wiki/JANUS_clinical_trial_data...

    Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.

  3. US FDA approves Ionis Pharma's genetic disorder drug - AOL

    www.aol.com/news/us-fda-approves-ionis-pharmas...

    (Reuters) -The U.S. Food and Drug Administration has approved Ionis Pharmaceuticals' drug to treat a rare genetic disorder, making it the company's first wholly-owned drug, the health regulator's ...

  4. FDA Gives Green Signal To Novavax's COVID-19-Influenza ... - AOL

    www.aol.com/fda-gives-green-signal-novavaxs...

    On Monday, the FDA removed the clinical hold on Novavax Inc.’s (NASDAQ:NVAX) Investigational New Drug (IND) application for its COVID-19-influenza combination (CIC) and stand-alone influenza ...

  5. US FDA staff questions confirmatory trial data for Intercept ...

    www.aol.com/news/fda-staff-raises-efficacy...

    Accelerated approvals allow FDA to move drugs for life-threatening conditions to the market more quickly, but they have been criticized because some drugs are later proven to be ineffective.

  6. Criticism of the Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Criticism_of_the_Food_and...

    Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines ...

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  8. US FDA mandates label updates on CAR-T cancer therapies - AOL

    www.aol.com/news/us-fda-mandates-label-updates...

    (Reuters) - The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called "boxed warning" to highlight the serious risk of ...

  9. Private Medicare plans must cover Biogen's ALS drug, US ...

    www.aol.com/news/private-medicare-plans-must...

    Qalsody received the U.S. Food and Drug Administration's accelerated approval last year, but CMS said it found many Medicare Advantage plans, which cover adults 65 years and older or those with ...