The U.S. Patent & Trademark Office (USPTO) selects 19 law schools to join its Law School Clinic Certification Pilot Program. Four of the law schools will join five others already participating in a clinical program that provides pro bono patent legal services to independent inventors and small businesses. Clients can expect through the program to receive professor-supervised searches and opinions, advice about IP needs, application drafting and filing, and representation before USPTO.
The U.S. Food and Drug Administration (FDA) schedules a September 5, 2014, public meeting “to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in drug and biologic development programs.” A live Webcast of the meeting will be available and can be viewed for one year on the Website of FDA collaborator the Brookings Institution. Comments are requested by November 5. The meeting will specifically focus on “identifying challenges for biomarker applications in early- and late-phase clinical trials and emerging best practices for successful biomarker-based programs, including codevelopment of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials.”
The U.S. Food and Drug Administration (FDA) issues guidance for industry and staff titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” The document describes the agency’s “current review practices for premarket notification submissions [for medical devices] by describing in greater detail the regulatory framework, policies, and practices underlying FDA’s review of traditional 510(k) submissions.” Comments on the guidance may be submitted at any time.
The U.S. Food and Drug Administration establishes a public docket as part of an initiative related to reserving proprietary names for drug products once the agency has “tentatively accepted” a proposed proprietary name. Stakeholders have apparently expressed concerns that the existing process for reserving names does not provide applicants with sufficient certainty before application approval that a proposed proprietary name will be included in approved drug labeling. New drug names can be rejected if they are likely to contribute to medication error or otherwise render the drug misbranded or if an intervening product approval involves a confusingly similar name. As to the latter, the agency may not be able to disclose certain information to applicants about other pending applications. Comments on these and related issues are requested by October 27, 2014.
The U.S. Food and Drug Administration (FDA) seeks public comments on the estimated time burdens relating to the extension of an existing information collection pertaining to the recalls of all FDA-regulated products (including food, animal feed, drugs, animal drugs, medical devices, cosmetics, biological products intended for human use, and tobacco). The estimates are based on the total number of recalls from 2011 to 2013 (11,403) averaged to 3,801 per year and involve the time burdens of complying with the voluntary reporting requirements of the agency’s recall regulations. Comments must be submitted by October 3, 2014.
The U.S. Food and Drug Administration announces the submission to the Office of Management and Budget of a proposed collection of information relating to a study of more than 6,000 adolescents, young adults and their parents to assess direct-to-consumer drug marketing to adolescents and how adolescents weigh risks and benefits. The agency included in the notice information about the estimated time burdens of the proposed surveys and its responses to comments from stakeholders when it previously announced the proposed experimental study. The questionnaire is available on request.
The U.S. Food and Drug Administration requests public comment on the estimated time burdens related to the extension of an existing information collection “associated with the medical device labeling regulations” as to certain products, including latex condoms, menstrual tampons, contact lens cleaning solution, impact resistant lenses, and sunlamp products. Comments are requested by September 30, 2014.