Document ID: FDA-2014-N-0157-0001
Agency: fda
Document Type: Notice
Title: Study Approaches and Methods To Evaluate the Safety of Drugs and
Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments
Posted Date: 2014-02-19T05:00Z

[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Notices]
[Pages 9469-9470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03589]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0157]

Study Approaches and Methods To Evaluate the Safety of Drugs and 
Biological Products During Pregnancy in the Post-Approval Setting; 
Public Meeting, Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Study Approaches and Methods to Evaluate the Safety 
of Drugs and Biological Products During Pregnancy in the Post-Approval 
Setting.'' The purpose of the public meeting is to engage in 
constructive dialogue and information sharing among regulators, 
researchers, the pharmaceutical industry, public health agencies, 
health care providers, and the general public concerning challenges in 
designing and implementing pregnancy registries and other methods of 
evaluating the post-approval safety profile of drugs and biological 
products in pregnant women. The input from this meeting and public 
docket will be used to support the revision of a guidance for industry 
on establishing pregnancy exposure registries.
    Dates and Times: The meeting will be held on May 28, 2014, from 8 
a.m. to 5 p.m. and May 29, 2014, from 8:30 a.m. to 12:30 p.m.
    Location: The meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Participants must enter 
through Building 1 and undergo security screening. For parking and 
security information, please visit http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Please arrive early to ensure time for parking and 
security screening.
    Contact Persons: For meeting background and content: Vicki Moyer, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6148, 
FAX: 301-796-9855, vicki.moyer@fda.hhs.gov. For registration, oral 
presentations, special accommodations, and other meeting logistics: 
Cherice Holloway, Center for

[[Page 9470]]

Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-4909, FAX 301-796-
9832, cherice.holloway@fda.hhs.gov.
    Registration and Requests for Oral Presentations: Registration is 
free and available on a first-come, first-served basis. You must 
register online by May 14, 2014. Seating is limited, so register early. 
FDA may limit the number of participants from each organization. If 
time and space permit, onsite registration on the day of the meeting 
will be available. To register for this meeting, please visit FDA's 
Drugs News & Events--Meetings, Conferences & Workshops calendar at 
http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm and select this 
meeting from the events list. If you need special accommodations due to 
a disability, please contact Cherice Holloway (see Contact Persons) at 
least 7 days before the meeting. Those without Internet access should 
contact Cherice Holloway to register.
    This meeting includes a public comment session. If you would like 
to present during this session, please identify the topic(s) you will 
address during registration (see Section II).
    FDA will do its best to accommodate requests to speak. FDA urges 
individuals and organizations with common interests to coordinate and 
give a joint, consolidated presentation. Following the close of 
registration, FDA will allot time for each presentation and notify 
presenters by May 20, 2014. Do not present or distribute commercial or 
promotional material during the meeting. Registered presenters should 
check in before the meeting.
    Live Webcast of the Meeting: To view the Connect Pro Webcast of 
this meeting, you must register online by 4 p.m., May 14, 2014. Webcast 
connections are limited, so register early. Organizations should 
register all viewers but access the Webcast using one connection per 
location.
    Webcast viewers will be sent system requirements after registration 
and will be sent connection information after May 21, 2014. Visit 
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm 
for the Connect Pro Connection Test. To get a quick overview of Connect 
Pro, visit http://www.adobe.com/go/connectpro_overview. (FDA has 
verified the Web site addresses in this notice but is not responsible 
for any subsequent address changes after this notice publishes in the 
Federal Register.)
    Comments: FDA is holding this meeting to obtain information on 
study approaches and methods to evaluate the safety of drugs and 
biological products during pregnancy in the post-approval setting. FDA 
is soliciting from interested persons electronic or written comments on 
all aspects of the meeting topics through June 30, 2014.
    Attendees and non-attendees may submit electronic comments to 
http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Send only one set of 
comments. When sending comments, please include the docket number from 
the heading of this notice. In addition, when addressing specific 
topics (see Section II), please identify the topic. Received comments 
may be viewed in the Division of Dockets Management between 9 a.m. and 
4 p.m., Monday through Friday and will be posted to the docket at 
http://www.regulations.gov.
    Transcripts: After the meeting, FDA will post a transcript at 
http://www.regulations.gov. The transcript may be viewed at the 
Division of Dockets Management (see Comments). A transcript will also 
be available in either hardcopy or on CD-ROM after submission of a 
Freedom of Information request. Send requests to the Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is holding this meeting to seek input from industry, academia, 
public health agencies, the clinical community, and other stakeholders 
regarding the structure and design of pregnancy registries. In 
addition, other methods of evaluating the safety profile of drugs and 
biological products in pregnant women in the post-approval setting will 
be explored.
    At the time of initial approval of a drug or biological product, 
there are generally very limited data on the safety of the product when 
used during pregnancy. Pregnancy registries provide post-approval 
safety information. In certain cases, these registries may be post-
marketing requirements. The goal of pregnancy registries is to evaluate 
the risk of birth defects or pregnancy complications related to use of 
a product and to use these data to inform safety-related product 
labeling.
    The purpose of the meeting is to engage in constructive dialogue 
and information sharing among regulators, researchers, the 
pharmaceutical industry, public health agencies, health care providers, 
and the general public concerning challenges in designing and 
implementing pregnancy registries. FDA is seeking feedback on practical 
approaches to improve pregnancy registries, as well as alternative 
approaches, to obtain robust scientific information on the rate and 
occurrence of birth defects or pregnancy complications related to the 
use of a product. Additionally, FDA is seeking input on best practices 
to communicate information to health care providers and patients about 
pregnancy registries and other post-approval studies in which pregnant 
women can enroll. Feedback from this meeting will be used to support 
revision of the current guidance for industry entitled ``Establishing 
Pregnancy Exposure Registries'' (August 2002), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071639.pdf.
    The meeting will include multiple sessions over 2 days.

II. Scope of the Meeting

    The objective of the meeting is to engage researchers, industry, 
public health agencies, health care providers, and the public through 
presentations and panel discussions on the following topics:
     Current status of pregnancy registries and challenges in 
gathering data regarding drug and biological products used during 
pregnancy. These challenges include, but are not limited to, low 
enrollment, poor followup rate, limited sample size, ascertainment of 
adverse outcomes, and appropriate comparator group selection.
     Strategies to improve the design and conduct of pregnancy 
registries.
     Alternative approaches, such as enhanced 
pharmacovigilance, claims-based database studies, prospective cohort or 
case control studies and other innovative methodologies, to obtain 
robust scientific information on the rate and occurrence of possible 
safety concerns related to the use of drugs and biological products 
during pregnancy.
     Best practices for communicating information to health 
care providers and patients about pregnancy registries and other post-
approval studies.
    Information about this meeting, including registration and the 
agenda, will be posted at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm as it becomes available.

    Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03589 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P