FDA Announces Precision Dosing Public Workshop for August 12, 2019

FDA Announces Precision Dosing Public Workshop for August 12, 2019

The Food and Drug Administration (FDA) in collaboration with the University of North Carolina will host a one-day public workshop entitled “Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting” on August 12, 2019.

Some clinical trials in drug development are conducted to optimize the dosing regimen of a new drug for the target patient population. Clinical pharmacology trials serve as the major source of evidence for dose individualization (precision dosing) based on patient factors that can modify drug response. Despite these efforts prior to a drug’s approval, further dose optimization may be required after drug approval (e.g., accounting for extremes of age, body habitus, organ function, and complex multiple characteristics including genotype, drug interactions, and co-morbidities).

The objectives of this workshop are to:

1. explore the need for more precise dosing;
2. investigate opportunities in the drug development and real-world settings to generate the information needed to support precision drug dosing; and
3. discuss the translation of the dosing information to electronic drug dosing delivery tools to enable precision dosing in clinical practice. Topics will be discussed from multiple perspectives including drug developers, regulators, physicians, pharmacists, and patients.

The date, time, location, and other details of the workshop are as follows:

Date: August 12, 2019

Time: 8:00 am – 5:00 pm

Location: Food and Drug Administration White Oak Campus, Great Room, Building 31, Room 1503 (B and C), 10903 New Hampshire Avenue, Silver Spring, MD 20993

Additional information on this workshop can be found at https://go.usa.gov/xmmGz.

Registration is free and can be accessed at https://www.eventbrite.com/e/fda-precision-dosing-workshop-registration-54003205040. The FDA will provide a free-of-charge, live webcast of this workshop. Recordings of the webcast will be made available after workshop completion.

This workshop will be open to the public and is intended for diverse groups from academia, industry, regulatory agencies, patient advocacy organizations, real-world data companies, and other individuals who have an interest in approaches to precision dosing and its impact in drug development and patient care.

For further information contact: OCPWorkshops@fda.hhs.gov or visit https://go.usa.gov/xmmGz.