(White Paper) This One’s for the Children: Progress in Pediatric Drug Development in the United States
Posted by Elizabeth P.Synterex, Inc.
13 days ago
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Synterex, Inc.
The agile clinical & regulatory consulting firm.Synterex, Inc.
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Defining the Value of Medical Affairs
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Defining the Value of Medical Affairs
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Calibration & PM Programs
Deviation Investigations
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Facility Maintenance Programs
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Corrective Action Verification
Deviation Investigation
Quality Process Governance
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Batch Release Testing
Raw Material Testing
Stability Program Testing
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Compliance
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Agency Meeting Support
Dossier & Application Development
eCTD Publishing & Validation
Pre-Submission Advisory Meetings
Regulatory Compliance
Labeling & Promotions
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Core Data Sheet Management
Labeling Strategy Development
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Post-Approval Safety Reporting
Promotional Material Compliance
Variations & Supplements
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Clinical Disclosure
Clinical Transparency
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Synterex, Inc.
Prior to the FD&C Act, pharmaceutical companies were not required to provide proof of drug safety or a disclosure of all active ingredients. Since then, all new drugs undergo an intensive review process by the Food and Drug Administration (FDA), and ever-evolving guidance and regulations ensure that both new drugs and those with updated characteristics, such as dosing, delivery, and expanded indications, are safe and effective for the intended populations. A gap remains, however, for drug investigations including and targeted for children of varying ages.
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