CRPV203 Regulatory Pathways of Drugs Licensing in US (FDCA, CFR, CTD)

In the United States, the regulatory pathways for drug licensing are governed by the Federal Food, Drug, and Cosmetic Act (FDCA) and the Code of Federal Regulations (CFR). The FDCA is the primary statute governing the regulation of drugs, medical devices, and food in the United States, while the CFR is a set of regulations issued by various federal agencies to implement and enforce the requirements of the FDCA.

This course describes the essential pathways and requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. Students will gain a practical understanding of the US drug licensing and privacy regulations as well as New Drug Application (NDA) and common technical document -CTD/eCTD’s processing. Similarities and differences between various medicinal products (e.g., generic, biologics, and orphan drugs) are discussed in detail.

Learning Points:

• Food, Drug, and Cosmetic Act (FDCA) and Code of Federal Regulations (CFR)
• NDA Modules
• NDA Submission Process to Obtain Approval to Market
• Submissions in the CTD/eCTD Format
• How to Gain Approval to Market Generic Drugs/FDA Bioequivalence Guidance
• The Regulatory Pathway to Licensing – Biologics
• Orphan Drugs Regulation