FDA
26th July 2013

AdComm Roll Call Special – Spotlight on: CRDAC

Much like ODAC, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is another somewhat infamous FDA advisory committee. CRDAC is charged with reviewing and evaluating the safety and effectiveness of marketed and investigational drugs for use in the treatment of cardiovascular and renal disorders. 

AdComm Roll Call Special – Spotlight on: CRDAC

Much like ODAC, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is another somewhat infamous FDA advisory committee. CRDAC is charged with reviewing and evaluating the safety and effectiveness of marketed and investigational drugs for use in the treatment of cardiovascular and renal disorders.

ODAC consists of 11 core, voting members including the Chair; there are currently 2 vacancies. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Temporary voting members may also be selected to join the committee, particularly when expertise is required that is not available among current voting standing members of the Committee.

The last time there was a CRDAC meeting was in September 2012 when they discussed the new drug application (NDA) 203009, lixivaptan, submitted by Cardiokine Biopharma, LLC, for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. They also discussed NDA 203826, phenylephrine hydrochloride injection, USP, submitted by West-Ward Pharmaceutical Corp., to increase blood pressure in acute hypotensive states, such as shock and peri-operative hypotension.

Although CRDAC has not met in almost a year, there is a 2-day meeting scheduled for August 5 & 6, 2013. On the first day, they will discuss NDA 204441 for tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure). On the second day, they will discuss NDA 204819, proposed trade name ADEMPAS (riociguat coated tablet), submitted by Bayer HealthCare Pharmaceuticals Inc., for the treatment of 1) chronic thromboembolic pulmonary hypertension (CTEPH) World Health Organization (WHO) Group 4 to improve exercise capacity and WHO functional class and 2) pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening.

 

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ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

 

 

 

 

 

 

 

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