The Food and Drug Administration (FDA) Will Host a Public Meeting to Seek Input on the Public Health and Drug Development Implications That May Result From Drug Interactions With Hormonal Contraceptives on November 9, 2015
The FDA will be holding a public meeting November 9, 2015, entitled “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications.” The goal of this public meeting is to provide an opportunity for FDA to seek input from experts on:
Public health concerns associated with use of Hormonal Contraceptives (HCs) with interacting drugs that may affect efficacy and safety;
Pharmacokinetic /pharmacodynamic considerations in designing drug interaction studies with HCs during drug development; and
Approaches to translating the results of drug interaction information into informative labeling and communication.
The input received may be used to refine FDA’s thinking on HC drug interaction study design and interpretation, and the communication of drug interaction risk in approved product labeling.
Date: Monday, November 9, 2015, 8:30 am - 4:30 pm
Location: FDA White Oak Campus, Section A of the Great Room (Rm. 1503 B and C)
Interested individuals can attend the meeting in person or via Web cast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. Please register by October 9, 2015.
Learn more about the event at: http://go.usa.gov/3twZw (FR notice: http://go.usa.gov/3twBj)
Register for the meeting at: https://www.surveymonkey.com/r/HC-DDIMeeting.
For further information contact: Christine Le, Pharm.D. (email: firstname.lastname@example.org).
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This burst was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.