Filter by
- United States. Food and Drug Administration 47
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- 6-O-Palmitoylascorbic Acid 1
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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
Assessment of the Real-World Safety Profile of Vedolizumab Using the United States Food and Drug Administration Adverse Event Reporting System
- Authors
- Raymond K. CrossMichael ChioreanFrancis VekemanYongling Xiao3 more author(s)...
- Description
For two decades the standard drug therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC) has been anti-tumor necrosis factor agents (anti-TNFs) such as adalimumab (Humira), certolizumab pegol (Cimzia), infliximab (Remicade) and several others. More recently, vedolizumab (Entyvio) has entered the market as the first gut-selective integrin blocker that offers an alternative treatment...
- Subject
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Colitis, Ulcerative/drug therapyCrohn Disease/drug therapyDrug-Related Side Effects and Adverse Reactions
- Access Rights
- Approval required
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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
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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
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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
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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
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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
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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