Good ANDA Submission Practices

Proactive Planning for the Best Possible Outcomes

Presented by Radhika Rajagopalan, Ph.D., EAS Independent Consultant

FDA recent draft and final guidance documents related to generic drugs indicate the Agency’s thinking with regards to spurring competition with the aim of lowering the high cost of medicines. As such generic drug manufacturers have an opportunity to streamline their ANDA submission processes to better incorporate FDA’s safety and efficacy expectations to include labeling considerations and controlled correspondence.

Being an early adopter of these improved practices will facilitate a timely review and increased the likelihood of approvals. Learn best practices for ANDA submissions with EAS Consulting Group and independent consultant and former FDA drug reviewer, Radhika Rajagopalan, Ph.D. She’ll discuss the recent guidance documents, distill what FDA is really looking for and how to best apply their principles to your submissions.

About the Presenter

Radhika Rajagopalan, Ph.D.

EAS Consulting Group Independent Consultant

EAS independent consultant, Radhika Rajagopalan, Ph.D. works in the pharmaceutical industry and has over 23 years of experience with dosage forms’ CMC sections for both 505(j) and 505 (b2) applications. She is an expert in CMC packages including ADNAs, DMFs (Type 2 and 4), INDs, Bio-INDs, OTC ANDAs, supplemental new drug applications, novel technology approval, drugs in device as well as devices co-packaged with drugs and works with clients to facilitate complex innovator and generic drug product reviews and approvals under User Fee Programs for nanotechnology products, gels, suppositories, modified release dosage forms, parenteral, drugs in device, peptides, semi-solids, and liposomal drug products.