FDA to Extend Comment Period on Proposed 505(b)(2) and ANDA Rule

Well, it took us since February to try to outline many of the major provisions of the 341 page Proposed Rule and now FDA has decided to grant a 30-day extension on comment to the Rule.  I am certain the 30 extra days is welcome by industry, due to the complexity and length of the Rule.  The date to comment is being extended to June 8, 2015, based on requests from the industry for more time to digest the Rule.

The Rule has an original 90-day comment period and we expect many comments to come rolling in.  Then, the process for reviewing and responding to all of the comments begins for the FDA.  See the full notice on the extension of the comment period here.