The new guidance provides the following timetable for mandatory compliance:
- May 5, 2017: Abbreviated New Drug Applications, Biologic
License Applications, Drug Master Files and New Drug Applications,
including all amendments, supplements, annual reports, etc. - May 5, 2018: Commercial Investigational New Drug applications,
including all amendments, annual reports, etc.
Note: The dates above are from the FDA Data Standards Catalog, version 4.3, dated May 27, 2015.
Presenter
Gina Ross, Managing Director, Regulatory Submission Operations has nearly 20 years of regulatory publishing and submission expertise. Let Cardinal Health help your organization prepare for this major change to the submission and approval process.
To schedule a meeting and find out how we can help your organization create and implement a transition plan and provide post-implementation support, call us at 913.451.3955 or email us at regulatoryscience@cardinalhealth.com.