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  1. News & Events for Human Drugs

Evaluation of the Safety of Drugs and Biological Products used during Lactation

Lactation Workshop Announcement

FDA’s Division of Pediatric and Maternal Health in CDER, is announcing a 2-day public workshop, “Evaluation of the Safety of Drugs and Biological Products used during Lactation”. The purpose of this 2-day workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data to inform about potential risks of medication use during lactation and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation.   Day 1 of the workshop will focus on review and discussion of current approaches for the collection of data, a review and discussion of gaps in our present knowledge and a discussion of strategies to communicate safety information related to maternal use of medications during lactation.  Day 2 of the workshop will be a discussion of the Day 1 information with a focus on consideration of novel approaches to improve the quality and quantity of data available to assess the safety of medications used during lactation.

The public workshop will be held on:

DATE: April 27 and 28, 2016

TIME: 8:00 a.m. to 5:00 p.m. (Day 1)

          8:00 a.m. to 1:00 p.m. (Day 2)

LOCATION:  The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Bldg. 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

REGISTRATION:  Participation can be either in person attendance or by webcast. There is no fee to attend the public workshop, but attendees should register in advance. Space is limited, and registration for in person attendance will be on a first-come, first-served basis. Persons interested in attending this workshop must register by sending an email to Lactation@fda.hhs.gov by April 8, 2016. Please include: 1) first and last name, 2) contact phone or email, 3) live attendance or via webcast 4) indicate if you plan to attend Day 1, Day 2 or both days. For those without Internet access, please contact Denise Pica-Branco at denise.picabranco@fda.hhs.gov or Denise.johnson-lyles@fda.hhs.gov to register. Onsite registration will not be available.

MORE INFORMATION: Contact Denise Pica-Branco, (301)796-1732; FAX (301)796-9858, e-mail denise.picabranco@fda.hhs.gov or Denise Johnson-Lyles, (301)796-6169; FAX (301)796-9858, e-mail denise.johnson-lyles@fda.hhs.gov
 

WEBCAST:   https://collaboration.fda.gov/lactation0416/

FINAL AGENDA PDF - 79KB)

Lactation Workshop Panel Discussion Questions (PDF - 46KB)

PRESENTATION SLIDES DAY 1

PRESENTATION SLIDES DAY 2

 

April 27:
 
 
April 28:

 

 

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