FDA to Extend Comment Period on Two Issues for Two Weeks

Two Federal Register notices that will both publish on November 27, 2013, extend the comment period for 14 days on two separate Draft Guidance documents, due to technical problems that occurred on the Regulations.gov website that made it impossible for some commenters to make electronic submissions to the respective Dockets from November 4-13, 2013.

The Dockets will stay open for an additional two weeks to receive comments on the Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate (see FR notice here) and the Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1) (see FR Notice here).

Both of these Draft Guidance documents address significant issues for the generic drug industry, so, if you still have comments to make, your window of opportunity is still open