Understanding the US FDA Drug Review and Approval Process
- Speaker:Dr. David Lim
- Product Code:GRC-90413
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Recorded Session - How it works
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Training CD - How it works
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Certification: GRCTS Completion Certificate
Why you must attend:
- 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.
- In 2014 and 2015, the FDA/CDER has approved 41 and 45 novel drugs, respectively.
- 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:
- FDA Guidances.
- Regulatory Requirements for New Drug Application (NDA) and Biologic License Application (BLA).
- Drug Development.
- FDA Drug Review and Approval.
- Common Mistakes.
- Critical Considerations.
- Enforcement Actions.
- Recent FDA Approvals.
- PASS-IT Recommendations.
Who will benefit :
- Compliance Officers.
- Regulatory Affairs.
- Clinical Affairs.
- Quality Assurance.
- Anyone Interested in the FDA Drug Review and Approval Processes.
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspection observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.
Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.