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). 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.
Join this session, where expert speaker David Lim, Ph.D., RAC, ASQ-CQA, will discuss the regulatory pathways, 505(b)2 for new drug applications (NDAs) and 505(j) for abbreviated new drug applications (ANDAs) and will give you a better understanding of the FDAâs regulatory pathways under sections of 505(b)2 and 505(j) of the FDCA. The session will provide you with a great opportunity to consider and use the regulatory pathways from practical and business perspectives. The session will further provide you with how to and practical tips as well as a great opportunity to help save your resources.
Who Should Attend?
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.