Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Michelle Anantha, MSPAS, PA-C, RAC
Senior Pharmacologist
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Michelle Anantha is a senior reviewer with the Good Clinical Practice (GCP) Compliance Oversight Branch in the Office of Scientific Investigations in CDER’s Office of Compliance. In her current role, she evaluates GCP-related referrals and complaints, as well as inspectional findings, regarding clinical investigators, sponsor-investigators, sponsors, contract research organizations, institutional review boards, and Radioactive Drug Research Committees. She and her colleagues work collaboratively to ensure subjects’ rights, safety, and welfare, and data integrity and reliability, in the conduct of clinical trials for human prescription drugs and therapeutic biologics.
Prior to joining FDA in 2004, Ms. Anantha clinically practiced as a Physician Assistant in oncology and internal medicine and worked in the pharmaceutical industry.
Abstract
Michelle Anantha presents on clinical investigator inspection readiness, offering practical guidance for navigating FDA inspections. She explains that the FDA evaluates clinical trial conduct for compliance with regulations and Good Clinical Practice (GCP), ensuring participant safety, welfare, and the reliability of submitted data. Inspections encompass two main types: routine/surveillance, conducted for pre-marketing reviews or general compliance, and for-cause, initiated to investigate allegations of potential violations. Anantha details the inspection sequence, which typically involves a pre-announcement, issuance of Form FDA 482 for domestic inspections, an opening meeting, review of paper and electronic records, interviews, and site walkthroughs. She clarifies that a Form FDA 483 summarizes observed conditions but does not necessarily constitute a regulatory violation; the center makes that determination. Clinical investigators have the option to submit a written response to a 483, providing corrective and preventive action plans (CAPA) and supporting documentation, which can influence the final compliance decision. FDA inspections are ultimately classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI), with OAI representing serious noncompliance that may lead to enforcement actions like warning letters or disqualification proceedings. Case examples illustrate how protocol deviations, such as exceeding pediatric dosing or unblinding assessors, result in OAI classifications due to compromised subject safety or data integrity. Anantha concludes by emphasizing that always being prepared is the best way to successfully navigate an FDA inspection.