On March 27, 2015, FDA will conduct a 1-day public meeting entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” The purpose of the meeting is to provide a public forum for FDA to listen to comments on
- the proposed rule on “changes being effected” supplements that was published in the Federal Register of November 13, 2013, and
- alternatives offered to this proposed rule.
FDA is also reopening the comment period for the proposed rule until April 27, 2015, to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.
March 27, 2015
8:00 a.m. to 5:00 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 (Great Room)
Silver Spring, MD 20993
Enter at Building 1 to clear security
(Information about arrival to FDA's White Oak campus)
The proposed rule would revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired safety-related information in advance of FDA’s review of the change by submitting a changes being effected (CBE-0) supplement to FDA. The need to promptly communicate certain safety-related labeling changes based on newly acquired information is the basis for the “changes being effected” exception to the general requirement for FDA approval of revised labeling prior to distribution. The proposed rule, if finalized, would enable application holders for generic drugs to update product labeling promptly to reflect certain types of newly acquired safety-related information, irrespective of whether the revised labeling differs from that of the corresponding reference listed drug (RLD or brand drug) upon submission of a CBE-0 supplement to FDA. FDA’s proposed revisions to its regulations to allow generic drug manufacturers to update product labeling through CBE-0 supplements in the same manner as brand drug manufacturers are intended to improve communication of important, newly acquired drug safety information to health care professionals and the public. For further information, please see the public docket for the proposed rule.
FDA received numerous comments on the proposed rule from a diverse group of stakeholders, including comments proposing alternative approaches to communicating newly acquired safety-related information in a multisource environment. In view of recent requests for a listening meeting and to promote transparency, FDA will hold a public meeting at which any stakeholders may present or comment on the proposed rule or any alternative proposals intended to improve communication of important newly acquired drug safety information to health care professionals and the public.
Registration to Attend the Public Meeting
If you would like to attend the public meeting, please register for the meeting by email to CBESupplements.PublicMeeting@fda.hhs.gov by March 20, 2015. The e-mail should contain complete contact information for each attendee (including name, title, firm name or affiliation, address, email, telephone and fax numbers). There is no fee to register for the meeting, and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
Registration to Present at the Public Meeting
Individuals who wish to present at the public meeting must register for the meeting by email to CBESupplements.PublicMeeting@fda.hhs.gov by March 16, 2015. The “Presentation Request” e-mail should contain complete contact information, including name, title, firm name or affiliation, address, email, telephone and fax numbers. You should provide a brief description of your presentation, and indicate the approximate desired length of your presentation, so that FDA can consider these in organizing the presentations.
- FDA will do its best to accommodate requests to speak and will notify each participant before the meeting of the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. An agenda will be posted on this Web page prior to the meeting.
- Presenters are encouraged to submit a copy of their presentation and related written material to the public docket in advance of the public meeting.
Access the webcast at: Public Meeting on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. This link will be active on the day of the meeting. Registration for the webcast is not required. Select “Enter as a Guest,” type your name, and click “Enter Room.”
Please allow time to locate parking, use the shuttle to Building 1, go through routine security procedures, and sign in. All visitors should park in the SE Quadrant Surface Lot. Visitors who have a mobility related disability should proceed to parking in the SE Quadrant Surface Lot. The shuttle which services this lot is handicap accessible. See Driving Directions and Parking for more information.
For additional information regarding the meeting, please see the Notice of Public Meeting.
- Federal Register Notice of Public Meeting
- Proposed Rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”
- Docket No. FDA-2013-N-0500 for Comments on the Proposed Rule and Related Documents
- Agenda (PDF - 26KB)
- Report an Adverse Event or Serious Problem to FDA