The U.S. Food and Drug Administration (FDA) announces the availability  of draft guidance for industry titled “Labeling for Human Prescription  Drug and Biological Products Approved under the Accelerated Approval  Regulatory Pathway.” The document presents FDA’s recommendations  for developing the indication and usage statements in the prescribing  information for drugs approved under the accelerated approval regulatory pathway. It also discusses “labeling considerations for indications  approved under accelerated approval when clinical benefit has been  verified and FDA terminates the conditions of accelerated approval, or  when FDA withdraws accelerated approval of an indication while other  indications for the drug remain approved.” Comments are requested by  May 27, 2014. 

The U.S. Patent and Trademark Office schedules an April 10, 2014,  roundtable event “regarding the use of crowdsourcing and third-party  preissuance submissions to identify relevant prior art and enhance the  quality of examination as well as the quality of issued patents.” Thosewishing to speak must have made their request in writing by March 27,  and those wishing to participate in person or via Webcast must register by  April 4. Comments are requested by April 25. 

The U.S. Patent and Trademark Office slates Patent Trial and Appeal  Board roundtables throughout the United States for administrative  patent judges “to share information about [inter partes review] trials and  collect public input and suggestions.” They will take place Tuesdays and  Thursdays, April 15 through May 8, 2014, in Alexandria, Virginia; New York  City; Chicago, Illinois; Detroit, Michigan; silicon Valley, California; seattle,  Washington; Dallas, Texas; and Denver, Colorado.

The U.S. Patent and Trademark Office launches a pilot program that  will require participants filing software-related patents to include a  glossary section in their patent application to define terms used in the  patent claims. The goal is to “enhance claim clarity in the specification of  software-related patent applications by encouraging and gauging the  use of glossaries by patent applicants.” Those participating in the program  “will receive expedited processing and be placed on an examiner’s special  docket prior to the first office action, and will have special status up to  issuance of a first office action.”