The U.S. Patent and Trademark Office (USPTO) seeks public comments by May 3, 2013, on “information requirements related to civil actions and claims involving current and former” USPTO employees. “The procedures under 37 CFR part 204 ensure that service of process intended for current and former employees of the USPTO is handled properly. The USPTO will only accept service of process for an employee acting in an official capacity. This collection is necessary so that respondents or their representatives can serve a summons or complaint on the USPTO, demand employee testimony and documents related to a legal proceeding, or file a claim under the Federal Tort Claims Act.”
The Food and Drug Administration (FDA) publishes a final rule “amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products.” The rule, which finalizes an interim rule published in 2001, takes effect March 28, 2013.
The Food and Drug Administration (FDA) issues a proposed rule that would “amend its regulations on acceptance of data from clinical studies for medical devices.” Under the proposal, clinical studies conducted outside the United States would have to “be conducted in accordance with good clinical practice, which includes obtaining and documenting the review and approval of the study by an independent ethics committee and obtaining and documenting freely given informed consent of study subjects.” The rule would apply to those studies used “as support for an investigational device exemption application, a premarket notification submission, a premarket approval application, a product development protocol application, or a humanitarian device exemption application.” Public comments are requested by May 28, 2013. The agency has proposed that the rule take effect 180 days after the final version is published in the Federal Register.
The Food and Drug Administration releases guidance for industry titled “Labeling for Human Prescription Drug and Biological Products—Implementing the Physician Labeling Rule Content and Format Requirements.” The document’s recommendations “will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products.” Comments may be submitted at any time.
The Food and Drug Administration (FDA) issues guidance “intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. Comments on the document may be submitted at any time. The guidance responds to Office of Inspector General recommendations to strengthen FDA’s oversight and review of clinical investigators’ financial disclosures.
The Food and Drug Administration (FDA) announces the availability of draft guidance “intended to assist applicants and FDA review staff in making decisions about the placement and content of pediatric information in human prescription drug and biological products labeling in accordance with the Best Pharmaceuticals for Children Act, as amended by the Food and Drug Administration Safety and Innovation Act, as well as FDA prescription drug and biological product labeling regulations.” Comments are requested by April 29, 2013.