The White House issues its “2013 Joint Strategic Plan on Intellectual Property Enforcement.” Among other things, the plan calls for an increased focus on the proliferation of counterfeit pharmaceuticals and medical devices and measures to strengthen intellectual property enforcement through international organizations.
The U.S. Patent and Trademark Office (USPTO) seeks comments under the Paperwork Reduction Act on the information required for service of process and to secure USPTO employee testimony and the production of documents in legal proceedings, as well as for filing claims against USPTO under the Federal Tort Claims Act. Rules for these and related legal processes are outlined in 37 C.F.R. Part 104. Comments and recommendations for the information collection are requested by August 2, 2013.
The U.S. Food and Drug Administration (FDA) schedules a July 12, 2013, public meeting for input on developing regulations that would implement Title VII of the Food and Drug Administration and Innovation Act as to “standards for the admission of imported drugs and commercial drug importers.” FDA invites meeting participants to address “the types of information that importers should be required to provide under Title VII” and “information regarding registration requirements for commercial drug importers and good importer practices to be established under Title VII.” Written comments are requested by August 12, 2013.
The U.S. Food and Drug Administration (FDA) announces the availability of draft guidance for industry titled “Expedited Programs for Serious Conditions—Drugs and Biologics.” The guidance provides “information on FDA’s policies and procedures related to expedited drug development and review programs” and applies to “new drugs to address unmet medical need in the treatment of serious or life-threatening conditions.” Comments on the draft are requested by August 26, 2013.
The U.S. Food and Drug Administration announces the availability of draft guidance titled “Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products.” “The draft guidance document provides sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products.” Comments on the draft are requested by November 22, 2013.