M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - Webinar
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M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - Webinar
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FDA CDER Small Business and Industry Assistance (SBIA)
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M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - Webinar
FDA CDER Small Business and Industry Assistance (SBIA)
FDA CDER Small Business and Industry Assistance (S...
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Defining the Value of Medical Affairs
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10
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3
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9
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43
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10
Stakeholder Influence Mapping
29
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Risk Management
19
Risk Evaluation & Minimization
16
Risk Management Evaluation
4
Safety Communications
3
Safety Systems
83
Safety Data Analytics
35
Safety Data Intake & Triage
33
Safety Signal Evaluation
23
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13
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1
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Clinical & Commercial Production
28
Labeling & Packaging
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Storage & Distribution
21
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Corrective Action Verification
51
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8
Quality Process Governance
23
Testing & Release
16
Batch Release Testing
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Raw Material Testing
12
Stability Program Testing
3
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Compliance
152
Agency Meeting Support
45
Dossier & Application Development
20
eCTD Publishing & Validation
10
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88
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2
Core Data Sheet Management
1
Labeling Strategy Development
1
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9
Post-Approval Safety Reporting
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4
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3
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Clinical Transparency
3
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1
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3
Data & Analytics
96
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46
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Data Curation
11
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44
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85
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1
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10
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25
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24
Show More (1)
Wearables & Sensors
29
Show Less (1)
Early Development
9
Clinical Supply Chain Automation
3
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7
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75
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8
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64
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This webinar will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.
Register here ➡️ M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - 11/21/2024 | FDA
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