Latest Federal Register Notices

DEVICES

Comments Sought on Device Educational Program Surveys Extension
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection on “Testing Communications on Medical Devices and Radiation-Emitting Products.” The testing is part of the agency’s research to ensure educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products are beneficial. To view the notice, click here.

Emergency Use Authorization Given to 4 Zika Tests
Federal Register Notice: FDA has announced the issuance of Emergency Use Authorizations for four in vitro diagnostic devices for detecting or diagnosing Zika virus. FDA issued the authorizations to Siemens Healthcare Diagnostics, Luminex, InBios International, and Roche Molecular Systems. To view this notice, click here.

Workshop Planned for Improving Hospital Device Surveillance
Federal Register Notice: FDA has announced a 12/5 public workshop on “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” The workshop is designed to explore the critical role of hospitals in the evolution of medical device surveillance and in creating more robust surveillance capabilities. The workshop will take place at the Fishers Lane Conference Center in Rockville, MD. To view this notice, click here.

DRUGS

Comments Sought on IND Reporting Requirements Extension
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to “Format and Content Requirements for OTC Drug Product Labeling — 21 CFR Part 201.” The regulations in Part 201 require OTC drug product labeling to include uniform headings and subheadings, presented in a standardized order, with minimum standards for type size and other graphical features. To view this notice, click here.

Draft Guide on Women Sexual Dysfunction Drugs
Federal Register Notice: FDA has made available a draft guidance on “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document is intended to assist sponsors in developing drugs for such conditions. It addresses FDA’s current thinking on the overall clinical development program, with a focus on Phase 3 trial designs. To view the guidance, click here. To view this notice, click here.

FDA Removing Ozone Exemption for Certain Anesthetics
Federal Register Proposed Rule: An FDA proposed rule seeks to remove an “essential uses” designation for certain ozone-depleting substances (ODSs) under the Clean Air Act. The action, if finalized, will remove the essential-use exemption for anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. FDA is proposing this action because these products are no longer being marketed in approved versions that contain ODSs and because alternative products that do not use ODSs are now available. To view the proposed rule, click here.

FDA Seeks OMB Approval for DTC Study
Federal Register Notice: FDA is seeking comments on a planned direct-to-consumer (DTC) advertising study that has been submitted to OMB for approval. The research will examine the growing use of animation in prescription drug advertising and promotional activities and whether such use minimizes risk or inflates efficacy perceptions. To view the notice, click here.