The U.S. Patent and Trademark Office creates the After Final Consideration Pilot Program 2.0 which modifies and extends a program designed to increase collaboration between patent applicants and examiners “to effectively advance the prosecution of the application” without resort to a request for continued examination. The program runs from May 19 to September 30, 2013.
The U.S. Patent and Trademark Office estimates and seeks public comment on the costs and burdens of various information collections related to procedures for actions taken after a patent is issued, such as requests to correct “errors in issued patents, to submit applications for reissue patents, and to submit issue fee payments.” Comments are requested by July 30, 2013.
The U.S. Food and Drug Administration (FDA) issues draft guidance on contract manufacturing. Titled “Contract Manufacturing Arrangements for Drugs: Quality Agreements,” the guidance describes the agency’s “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, [FDA] describe[s] how parties involving in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.” Comments are requested by July 29, 2013.