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- 6-O-Palmitoylascorbic Acid 1
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UMB Dataset
Substances nominated for inclusion on the 503B Bulks List: Estradiol Cypionate
- Alternate Title(s)
- Estradiol Cypionate: 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
-
Drug CompoundingLegislation, DrugUnited States. Food and Drug Administration
- Access Rights
- Unrestricted access
-
UMB Dataset
Dataset for Communicating Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone
- Authors
- Peter DoshiO'Mareen SpenceAida KuzucanJohn H. Powers, III
- Description
This dataset is the result of an investigation characterizing nonefficacy benefits of newly approved molecular entities (NMEs) based exclusively on noninferiority trials. Qualifying NMEs were identified using the FDA’s Novel Drug Approval website, sponsor press releases at market entry, FDA Drug Trials Snapshots, and statistical and medical officer reports. A total of 18 were selected for analysis....
- Subject
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Drug IndustryEquivalence Trials as TopicHuman Experimentation/ethicsUnited States. Food and Drug Administration
- Access Rights
- Unrestricted access
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UMB Dataset
Substances nominated for inclusion on the 503B Bulks List: Alpha Lipoic Acid
- Alternate Title(s)
- Alpha Lipoic Acid: 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
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Drug CompoundingLegislation, DrugThioctic AcidUnited 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. 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
-
Aluminum ChlorideDrug CompoundingLegislation, DrugUnited 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. 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
-
6-O-Palmitoylascorbic AcidDrug CompoundingLegislation, DrugUnited 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. 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
-
Bismuth NitrateDrug CompoundingLegislation, DrugUnited 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. 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
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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
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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: 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
-
BetahistineDrug CompoundingLegislation, DrugUnited States. Food and Drug Administration
- Access Rights
- Unrestricted access