Latest Federal Register Notices
Draft Guide on Drug Master Files
Federal Register notice: FDA makes available a draft guidance entitled “Drug Master Files.” 10/18/2019
10 Info Collections Approved by OMB
Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB. 10/18/2019
FDA/Health Canada ICH Public Meeting
Federal Register notice: FDA announces an 11/4 regional public meeting between Health Canada and FDA on the International Council for Harmonization pharmaceutical regulatory activities. 10/17/2019
Info Collection Extension on Tobacco Form
Federal Register notice: FDA seeks comments on an information collection extension entitled “Potential Tobacco Product Violations Reporting Form.” 10/15/2019
CDRH Listing on Upcoming Guidance Documents
Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. 10/11/2019
Info Collection on 510(k) 3rd-party Reviews
Federal Register notice: FDA submits to OMB an information collection extension for “510(k) Third-Party Review Program.” 10/11/2019
Info Collection Extension for CVM eSubmissions
Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvm’s electronic submission system. 10/11/2019