Dr. Rajagopalan has extensive experience in the review and approval of Generic Drugs with OGD. She has been a Chemistry, Manufacturing, and Controls (CMC) reviewer, Special Assistant to the Deputy Director, and a Team Leader. Radhika has chaired the Stability Work Group Chair since its inception in 2011. She has ~ 7 years of Pharma industry experience prior to joining the FDA. Under her leadership, the stability work group has pursued implementing ICH stability guidances for the generic ANDA and Drug Master File (DMF) submissions, and has published the draft and final guidance for the stability testing of ANDAs in the Federal Register. In addition, draft Q & A guidance on ANDAs: Stability Testing is also published in the Federal Register on August 26th, which is the subject of discussion today.
During her FDA tenure she has chaired the CMC-Analytical methods technical committee 1999-2001 (AMTC), completed Excellence in Government Fellows Program for Leadership, published papers, and represented the Agency as a speaker in several National, international, and Trade meetings. In August 2000, the ‘Draft Guidance for Industry – Analytical Procedures and Methods Validation’, was published, when she chaired the committee. Dr. Rajagopalan continues to contribute to FDA-Industry workshops, training events, initiates regulatory research, CMC policy implementation efforts such as draft and final guidance development initiatives, in addition to approving several generic drug applications.