US FDA Drug Review and Approval Process

🎤  Joy McElroy      |  📅  Recording Available   |  🕒  60 Minutes 

Who Should Attend:  Quality Assurance Departments Research and Development Departments Regulatory Affairs Departments Compliance Officers Clinical Affairs Professionals Consultants Contractors/Subcontractors Everyone Interested in the FDA Drug Review and Approval Processes

Description:

The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs. To introduce a new drug product into the U.S. market, some firms submit a new drug application (NDA) to the US FDA/CDER. The firms are responsible for testing a drug and for submitting evidence that the drug is safe and effective.

This webinar is intended to help you better understand FDA’s drug review and approval process. The FDA’s recent approvals of novel drugs will also be discussed. The speaker will walk you through the regulatory requirements for FDA’s drug review and approvals.

Areas Covered in the Session:

• Latest Laws and Regulations
• Recent FDA Guidances and Definitions
• Regulatory Requirements for New Drug Application (NDA) and Biologics License Application (BLA)
• Drug Development
• FDA Drug Review and Approval
• Common Mistakes
• Critical Considerations
• Enforcement Actions
• Recent FDA Approvals
• Best Practices and Recommendations