The U.S. Patent and Trademark Office (USPTO) schedules a September 6, 2012, roundtable “to obtain public input from organizations and individuals on issues relating to the USPTO’s proposed implementation of the first-inventorto- file provisions of the [America Invents Act].”  

The Food and Drug Administration (FDA) advises applicants no longer seeking approval of their pending original abbreviated new drug applications (ANDAs) “to withdraw them as soon as possible to avoid paying a fee.” The one-time fee, authorized under the Generic Drug User Fee Amendments of 2012, “will apply to any original ANDA that is pending (neither withdrawn nor tentatively approved) at FDA on October 1, 2012.” The fee could amount to $25,000 per application depending on the number of ANDAs pending and not withdrawn by that date.  

The Food and Drug Administration (FDA) requests public comments by October 26, 2012, about draft guidance for industry on self-identification of generic drug facilities, sites and organizations. The guidance aims to assist industry as it prepares to meet identification information requirements under the Generic Drug User Fee Amendments of 2012 and “explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.”

The Food and Drug Administration (FDA) also requests public comments by October 26, 2012, about draft guidance for industry on generic drug user fee amendments of 2012. “This guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of the [Generic Drug User Fee Amendments of 2012].” According to FDA, new user fees will be determined after generic drug facilities, sites and organizations complete the self-identification process.

The Food and Drug Administration (FDA) schedules a September 21, 2012, public meeting “to discuss implementation of the Generic Drug User Fee Amendments of 2012” (GDUFA). While comments should be submitted before the meeting, the deadline for submission is October 12. Those wishing to attend and/or present at the meeting must notify FDA by September 14. The public will have the opportunity to discuss views on the guidance and other materials FDA has issued pertaining to its implementation of the GDUFA.