Elite Pharmaceuticals Inc (ELTP)

[KravMD]

I contacted the FDA to try and obtain more information on when was the latest they could notify ELTP concerning an ADCOM meeting. They replied the following, most information has already been shared on this board, but I thought I'd post it anyway. I hope some of you find this useful.


Dear Dr. ___________,

Thank you for writing to the Division of Drug Information, Small Business and Industry Assistance (SBIA), in the FDA's Center for Drug Evaluation and Research.

For more information about the review timeline, please refer to Guidance for Review Staff and Industry, Good Review Management Principles and Practices for PDUFA Products, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079748.pdf.

Please note that the FDA will not confirm an Advisory Committee meeting until publication of a Federal Register (FR) Notice. To view FDA Federal Register Notices and new publications of Federal Register Notices, please see the following website: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.

Under the PDUFA provisions, submission of a major amendment during the last 3 months of a review may trigger a 3-month extension of the review clock. The Agency decides whether to extend the review clock in response to such amendments. This decision is based on a variety of factors (e.g., content of the amendments, FDA workload and resources, existence of other known deficiencies that may affect approval and have not been addressed by the amendment), but the underlying principle is to consider the most efficient path toward completion of a comprehensive review that addresses application deficiencies and leads toward a first cycle approval when possible.

Additional information about factors the FDA considers in deciding whether to refer a matter to an advisory committee for consideration can be found at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125651.pdf.

You may also find information found at the following links useful:
Regulations governing the advisory committee can be found in 21 CFR Part 14 at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=14;
Common Questions and Answers about FDA Advisory Committee Meetings, http://www.fda.gov/advisorycommittees/aboutadvisorycommittees/ucm408555.htm.

We hope the information provided is helpful.

Best regards,

AA
Drug Information Specialist
CDER Small Business and Industry Assistance
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration