FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Allows More Time for Comment on Two Guidances

Jan. 19, 2018

The FDA extended the comment period for a guidance on pediatric orphan drugs and reopened the comment period for a guidance on ANDA submissions.

The comment period for the Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases will be open through Feb. 18.

The guidance on Determining Whether To Submit an Abbreviated New Drug Application or 505(b)(2) Application was reopened for comment for 30 days on Jan. 12.

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