NCRAF Seminar: Key Considerations for Developing a Draft Package Insert

Description

Sathya Ganesan, Associate Director, Regulatory Affairs, G1 Therapeutics

A crucial document that is part of a dialogue between the sponsor and the regulatory agency during the filing and subsequent review of a New Drug Application is the Draft Package Insert provided in Module 1. The labeling section of the application provides the prescribing physician with key information on the product, starting with indication statement, dosage, adverse effects, potential warnings and contraindications, pharmacology and drug-drug interactions, and supportive evidence of efficacy. Sections of the package insert also provide useful information for any specific counseling information to be provided to the patient. The Package Insert is a living document which is revised periodically post-approval based on new emerging data such as safety information, special populations such as pediatric or geriatric use or a new indication. While it is not possible to cover all aspects of the draft package insert development in one seminar, FDA guidance specific to key sections of the label and precedents for oncology products will be reviewed in this webinar, encouraging discussion from participants on their recent experience.

Sathya Ganesan is a Director of Regulatory Affairs at G1 Therapeutics in RTP. She provides strategic regulatory support for clinical development including health authority interactions, pediatric plan, IND and CTA submissions, and strategy support for the company's first NDA and is a lead for draft package insert. Prior to G1, Sathya worked at PPD as a Global Regulatory Affairs Lead for pharma, biotech and government customers for Phase II and III studies while providing support for business development activities for new bids and awards. Sathya started her regulatory career at Grifols, where she coordinated regulatory activities for filing to US IND and Health Canada CTA for products in the R&D pipeline. Sathya received her PhD in Biochemistry from the University of Rochester and pursued bench research at Duke University as a postdoctoral fellow and as a product development scientist at Affinergy, LLC.