Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways

• Main Authors: Erica M. Cox (Author), Anita V. Edmund (Author), Erica Kratz (Author), Sarah H. Lockwood (Author), Aishwarya Shankar (Author)
• Format: Book
• Published: Wiley, 2020-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the mar...