UMB Data Catalog

A project of the Health Sciences and Human Services Library
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Results Found: 46
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Boric Acid

    Alternate Title(s)
    Boric Acid: Summary Report
    Authors
    Melissa V. Yuen
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Boric Acid
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Amphotericin B

    Alternate Title(s)
    Amphotericin B: Summary Report
    Authors
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    SeJeong Yoon
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Amphotericin B
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Benzocaine

    Alternate Title(s)
    Benzocaine: Summary Report
    Authors
    Melissa V. Yuen
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Benzocaine
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Chloral Hydrate

    Alternate Title(s)
    Chloral Hydrate: Summary Report
    Authors
    Melissa V. Yuen
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Chloral Hydrate
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Coenzyme Q10

    Alternate Title(s)
    Coenzyme Q10: Summary Report
    Authors
    SeJeong Yoon
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Coenzyme Q10
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Cantharidin

    Alternate Title(s)
    Cantharidin: Summary Report
    Authors
    Melissa V. Yuen
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Cantharidin
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Clioquinol

    Alternate Title(s)
    Clioquinol: Summary Report
    Authors
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    SeJeong Yoon
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Clioquinol
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Citrulline

    Alternate Title(s)
    Citrulline: Summary Report
    Authors
    Melissa V. Yuen
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Citrulline
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Diiodohydroxyquinoline

    Alternate Title(s)
    Diiodohydroxyquinoline: Summary Report
    Authors
    SeJeong Yoon
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Drug Compounding
    Iodoquinol
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Dexamethasone Acetate

    Alternate Title(s)
    Dexamethasone Acetate: Summary Report
    Authors
    SeJeong Yoon
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Dexamethasone Acetate
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access