FDA Announces a Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting will be held on March 15, 2017

FDA Announces a Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting will be held on March 15, 2017

The Food and Drug Administration (FDA) will hold a public meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee.  The committee will discuss strategies, approaches, and challenges in model-informed drug development (MIDD) for new and generic drugs with specific focus on two areas.  During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle.  During the afternoon session, the committee will discuss mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias.  The Comprehensive In Vitro Proarrhythmia Assay will be discussed as an example.

The Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting will be held in conjunction with the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2017 Annual Meeting: Advancing Patient Care Through Precision and Translational Medicine on March 15 – 18, 2017 in Washington, DC.

The date, time, and location of the Advisory Committee meeting are as follows:

Date:  March 15, 2017
Time:  7:30 a.m. to 3:45 p.m. 
Location:  Omni Shoreham Hotel, the Ballroom, 2500 Calvert St. NW, Washington, DC 20008

The meeting will be open to the public.  In addition, written comments can be sent to the docket (FDA–2010–N–0067) which will close on April 14, 2017.

FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, ACPSCP@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area).

Meeting materials will be available prior to the meeting at: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm535513.htm.

 Additional information about this meeting, including instructions for submitting either electronic or written comments, is available at http://go.usa.gov/x9QH7.

We always welcome your thoughts regarding the format, content, and utility of information you receive via this Burst email initiative.  Comments may be sent via email to ocp@fda.hhs.gov.

This burst was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology
Email: ocp@fda.hhs.gov