(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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Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
Back
13 days ago
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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