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  2. List of drugs granted breakthrough therapy designation

    en.wikipedia.org/wiki/List_of_drugs_granted...

    Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.

  3. List of free and open-source software packages - Wikipedia

    en.wikipedia.org/wiki/List_of_free_and_open...

    This is a list of free and open-source software packages, computer software licensed under free software licenses and open-source licenses. Software that fits the Free Software Definition may be more appropriately called free software ; the GNU project in particular objects to their works being referred to as open-source . [ 1 ]

  4. FDA Center for Devices and Radiological Health - Wikipedia

    en.wikipedia.org/wiki/FDA_Center_for_Devices_and...

    FDA Laboratory Building 62 (Engineering and Physics) houses the Center for Devices and Radiological Health. The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.

  5. ClinicalTrials.gov - Wikipedia

    en.wikipedia.org/wiki/ClinicalTrials.gov

    Bethesda, Maryland, U.S. Agency executive. Rebecca J. Williams, Director. Website. ClinicalTrials.gov. ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and holds registrations from over 444,000 trials from 221 countries.

  6. Breakthrough therapy - Wikipedia

    en.wikipedia.org/wiki/Breakthrough_therapy

    Retrieved 9 October 2017. A breakthrough therapy is a drug: • intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and. • preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically ...

  7. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...

  8. US FDA approves Citius' therapy for rare blood cancer - AOL

    www.aol.com/news/us-fda-approves-citius-blood...

    August 8, 2024 at 10:55 AM. By Mariam Sunny. (Reuters) -The U.S. Food and Drug Administration has approved Citius Pharmaceuticals' therapy for patients with a form of blood cancer who have ...

  9. 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. The analogy is that the Janus data ...