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U.S. Department of Health and Human Services

About FDA

Number of initial advisory meeting requests received in the month

Dictionary: Biosimilar Initial Advisory meeting is an initial assessment limited to a general discussion regarding whether licensure under section 351(k) of the PHS Act may be feasible for a particular product, and, if so, general advice on the expected content of the development program. This meeting type does not include any meeting that involves substantive review of summary data or full study reports.

Information is current as of December 31, 2013.

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A0
Nov 2013N/A0
Dec 2013N/A1
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 1

Footnotes

  • CDER began collecting data for these measures in January 2013.

Number of intial advisory meeting held in the month

Information is current as of March 31, 2013.

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A0
Nov 2013N/A0
Dec 2013N/A0
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 0

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.