The U.S. Food and Drug Administration (FDA) issues final guidance for industry titled “Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act.” The document provides information describing (i) the types of safety labeling changes that certain drug and biological product application holders might be required to make under the Food and Drug Administration Amendments Act of 2007 in light of safety information that becomes available after the drug or biological product has been approved; (ii) “how FDA plans to determine what constitutes new safety information; [iii] the procedures involved in requiring safety labeling changes; and [iv] enforcement of the requirements for safety labeling changes.” Comments may be submitted at any time.
The U.S. Patent and Trademark Office extends until August 21, 2013, the deadline for public comment “regarding the processes, data metrics, and methodologies that could be used to assess the effectiveness of cooperative agreements and other voluntary initiatives to reduce intellectual property infringement that occurs online—such as copyright piracy and trademark infringement” as part of its “Voluntary Best Practices Study.”
The U.S. Food and Drug Administration (FDA) issues a notice as to the availability of a draft guidance for industry titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” The guidance defines “the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection,” when FDA has concerns about adulterated drugs. Comments on the draft are requested by September 13, 2013.
The U.S. Food and Drug Administration announces the availability of draft guidance for industry titled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans” (PSPs). The document is intended “to assist sponsors in the submission of an initial PSP and any amendments to the PSP,” including who must submit these plans, when they must be submitted and what should be included in the plans. Comments on the draft are requested by September 13, 2013.
The Centers for Disease Control and Prevention (CDC) issues a direct final rule and request for comments on certain housekeeping changes to regulations titled “Distribution of Reference Biological Standards and Biological Preparations,” at 42 C.F.R. Part 7. The changes include updating references to the CDC, which has undergone a name change since the regulations were adopted, and a mailing address. Unless significant adverse comment is submitted before August 21, 2013, the rule will take effect September 20.
The U.S. Food and Drug Administration schedules a public workshop “to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products.” Those wishing to participate should register by September 23, 2013. The October 7 workshop will also be available via streaming Webcast. The agency is hoping to coordinate existing efforts in this arena and will also discuss “areas of high interest for current or future standards development” and “explore ways to minimize redundancy and maximize collaboration.”