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FDA to Extend Comment Period on Proposed Rule on Abbreviated New Drug Applications and 505(b)(2) Applications

FDA to Extend Comment Period on Proposed Rule on Abbreviated New Drug Applications and 505(b)(2) Applications

[4/15/2015] FDA has decided to extend the comment period by 30 days for the proposed rule on “Abbreviated New Drug Applications [ANDAs] and 505(b)(2) Applications.”  The comment period on the proposed rule will be extended to June 8, 2015.  This extension is being provided in response to requests to provide interested persons with additional time to submit comments.  FDA is expediting publication of a notice in the Federal Register to extend the comment period.

In the Federal Register of February 6, 2015, FDA published a proposed rule with a 90-day comment period to request comments on its proposal to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and ANDAs.  FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.  Comments on the proposed rule will inform FDA's rulemaking on ANDAs and 505(b)(2) applications.

Submit comments electronically to the FDA docket on http://www.regulations.gov, use docket number FDA-2011-N-0830.

To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All submissions must include the agency name and docket number.