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Results Found: 46
  • Substances nominated for inclusion on the 503B Bulks List: Estradiol Cypionate
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, estradiol cypionate, were summarized in the Estradiol Cypionate: Summary Report accessible via the UMB Digital Archive.

    Subject
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Alpha Lipoic Acid
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, alpha lipoic acid, were summarized in the Alpha Lipoic Acid: Summary Report accessible via the UMB Digital Archive.

    Subject
    Drug Compounding
    Legislation, Drug
    Thioctic Acid
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Ascorbyl Palmitate
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, ascorbyl palmitate, were summarized in the Ascorbyl Palmitate: Summary Report accessible via the UMB Digital Archive.

    Subject
    6-O-Palmitoylascorbic Acid
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Aluminum Chloride Hexahydrate
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, aluminum chloride hexahydrate, were summarized in the Aluminum Chloride Hexahydrate: Summary Report accessible via the UMB Digital Archive.

    Subject
    Aluminum Chloride
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Amphotericin B
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, Amphotericin B, were summarized in the Amphotericin B: Summary Report accessible via the UMB Digital Archive.

    Subject
    Amphotericin B
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Bismuth Nitrate Oxide
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, bismuth nitrate oxide, were summarized in the Bismuth Nitrate Oxide: Summary Report accessible via the UMB Digital Archive.

    Subject
    Bismuth Nitrate
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Brilliant Blue G
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, brilliant blue G, were summarized in the Brilliant Blue G: Summary Report accessible via the UMB Digital Archive.

    Subject
    Coomassie Brilliant Blue
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Boric Acid
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, boric acid, were summarized in the Boric Acid: Summary Report accessible via the UMB Digital Archive.

    Subject
    Boric Acid
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Cantharidin
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, cantharidin, were summarized in the Cantharidin: Summary Report accessible via the UMB Digital Archive.

    Subject
    Cantharidin
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access
  • Substances nominated for inclusion on the 503B Bulks List: Benzocaine
    UMB Dataset

    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 Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. The data on findings for the nominated substance, benzocaine, were summarized in the Benzocaine: Summary Report accessible via the UMB Digital Archive.

    Subject
    Benzocaine
    Drug Compounding
    Legislation, Drug
    United States. Food and Drug Administration
    Geographic Coverage
    United States
    Access Rights
    Unrestricted access