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- Drug Compounding 46
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- 6-O-Palmitoylascorbic Acid 1
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UMB Dataset
Substances nominated for inclusion on the 503B Bulks List: Boric Acid
- Alternate Title(s)
- Boric Acid: Summary Report
- Authors
- Melissa V. YuenStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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 AcidDrug CompoundingLegislation, DrugUnited 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. GianturcoLaura L. PavlechKathena D. StormSeJeong Yoon2 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 BDrug CompoundingLegislation, DrugUnited 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. YuenStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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
-
BenzocaineDrug CompoundingLegislation, DrugUnited 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. YuenStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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 HydrateDrug CompoundingLegislation, DrugUnited 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 YoonStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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 Q10Drug CompoundingLegislation, DrugUnited 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. YuenStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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
-
CantharidinDrug CompoundingLegislation, DrugUnited 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. GianturcoLaura L. PavlechKathena D. StormSeJeong Yoon2 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
-
ClioquinolDrug CompoundingLegislation, DrugUnited 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. YuenStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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
-
CitrullineDrug CompoundingLegislation, DrugUnited 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 YoonStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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 CompoundingIodoquinolLegislation, DrugUnited 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 YoonStephanie L. GianturcoLaura L. PavlechKathena D. Storm2 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 AcetateDrug CompoundingLegislation, DrugUnited States. Food and Drug Administration
- Access Rights
- Unrestricted access