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The United States Food and Drug Administration (FDA) approves news drugs and generic drugs under distinct regulatory pathways covered under Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA or the Act).
conference, the regulatory pathways, 505(b)2 for NDAs and 505(j) for ANDAs,
will be discussed. For firms
to bring certain new and generic drug products into the US market, it is
critical to understand how to best use the distinct regulatory pathways.
This seminar will help you better understand FDA’s regulatory pathways under sections of 505(b)2 and 505(j) of the FDCA. This conference will provide a great opportunity to consider and use the regulatory pathways from practical and business perspectives.
- Applicable Laws
- 505(b)2 and
- CMC Requirements
- Drug Examples
Approved under 505(b)2 and 505(j)
- Best Practices:
Dos and Don’ts
- Speaker’s PASS-IT Recommendations
Who will benefit:
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Anyone Interested in the FDA Drug Regulatory Pathways
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. 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 seven 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.