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U.S. Department of Health and Human Services

About FDA

Percentage of new or reformulated infant formula notification reviews completed during the month within 90 days of filing

Dictionary: Timely review of notifications for new and reformulated infant formulas is essential for protecting the health and well being of infants. Since these statutory requirements are notifications rather than pre-market approvals, it is essential that ONLDS have completed review of the information before the submitter markets the product, to notify them of any safety or regulatory concerns before the product reaches consumers.

Information is current as of December 31, 2014.

Fiscal Year - 2015

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TimeTargetPercentage
Oct 201490100
Nov 201490100
Dec 201490100
Jan 201590TBD
Feb 201490TBD
Mar 201590TBD
Apr 201590TBD
May 201590TBD
Jun 201590TBD
Jul 201590TBD
Aug 201590TBD
Sep 201590TBD

FY 2015 YTD: 100%

Number of new or reformulated infant formula notification reviews due to be completed during the month

Fiscal Year - 2015
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TimeTargetNumber
Oct 2014N/A3
Nov 2014N/A3
Dec 2014N/A1
Jan 2015N/ATBD
Feb 2014N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 7

Number of infant formula notification reviews completed during the month within 90 days of filing

Fiscal Year - 2015
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TimeTargetNumber
Oct 2014N/A3
Nov 2014N/A3
Dec 2014N/A1
Jan 2015N/ATBD
Feb 2014N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 7

Total number of infant formula notification reviews completed during the month

Fiscal Year - 2015
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2014N/A3
Nov 2014N/A3
Dec 2014N/A1
Jan 2015N/ATBD
Feb 2014N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 7

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.