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: Estradiol Cypionate

    Alternate Title(s)
    Estradiol Cypionate: 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
    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: Alpha Lipoic Acid

    Alternate Title(s)
    Alpha Lipoic Acid: 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
    Legislation, Drug
    Thioctic Acid
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Aluminum Chloride Hexahydrate

    Alternate Title(s)
    Aluminum Chloride Hexahydrate: 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
    Aluminum Chloride
    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: Ascorbyl Palmitate

    Alternate Title(s)
    Ascorbyl Palmitate: 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
    6-O-Palmitoylascorbic 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: Bismuth Nitrate Oxide

    Alternate Title(s)
    Bismuth Nitrate Oxide: 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
    Bismuth Nitrate
    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: 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: Betahistine HCl

    Alternate Title(s)
    Betahistine HCl: Summary Report
    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
    Betahistine
    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: Brilliant Blue G

    Alternate Title(s)
    Brilliant Blue G: Summary Report
    Authors
    Ashlee N. Mattingly
    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
    Coomassie Brilliant Blue
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access