The U.S. Food and Drug Administration (FDA) often schedules a Cardio-Renal Advisory Committee Meeting to address applications for products from anticoagulants to antiarrhythmics; from agents to prevent the rejection of transplanted kidneys to antihypertensives. Between these product approval meetings, FDA convenes to discuss the safety and labeling of currently marketed agents (e.g., treatments for anemia) as well as to encourage the articulation of new standards for drug development (e.g., the appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events in patients with aspirin intolerance due to immunologically-based adverse reactions, specifically in the setting of coronary artery bypass grafting) and the review of post-approval outcomes studies that call previous indications or approvals into question.
ECG has extensive experience preparing clients to face the CRDAC for both the Division of Cardio-Renal Drug Products and the Division of Hematology Products of FDA. From the results of major cardiovascular outcomes trials to an orphan drug application for pulmonary arterial hypertension (PAH), ECG's experience with the Cardio-Renal Committee covers a wide variety of meeting topics. We have supported our clients numerous times for product approvals in the following categories:
- Anticoagulant
- Antiplatelet
- Antihypertensive
- Antiarrhythmic
- Endothelin Receptor Antagonist (ERA)
- Erythropoietin Stimulating Agent
- MRI and Ultrasound Imaging Agent
- Selective T-cell Costimulation Blocker
Specific products in these categories were reviewed for a variety of indications including atrial fibrillation, acute coronary syndrome, anemia, treatment and prevention of venous thromboembolic events, hypertension, pulmonary arterial hypertension, and renal transplant protection.
ECG assists clients in preparing for every aspect of an Advisory Committee meeting, from helping guide the development of the briefing document and presentation to preparing for challenging questions; from recruiting panelists for mock AdComm meetings to the making and managing of extensive inventories of back-up slides; from the building of an AdComm preparation project plan to the travel and logistics of supporting a team in off-site meetings and at FDA's White Oak Great Room.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming CRDAC meeting.
