Understanding the US FDA Drug Review and Approval Process

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  1. 1. Understanding the US FDA Drug Review and Approval Process Speaker: David Lim| Date: 15th June 2016 2016 2016 | 10:00 AM PST | 01:00 PM EST Contact Us : Email: support@grcts.com | Tel: +1-248-233-2049
  2. 2. Description: The FDAs 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 FDAs drug review and approval process. The FDAs recent approvals of novel drugs will also be discussed.
  3. 3. Areas Covered in the Session: Regulations FDA Guidance's Definitions Drug Development FDA Drug Review and Approval Common Mistakes Critical Considerations Enforcement Actions Recent FDA Approvals PASS-IT Recommendations
  4. 4. Who will benefit: CEOs VPs Compliance Officers Attorneys Regulatory Affairs Clinical Affairs Quality Assurance R&D
  5. 5. Instructor Profile : Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). 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 inspectional 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 FDAs 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.