Latest Federal Register Notices
Comments Sought on Info Collection for CDRH Appeals
Federal Register notice: FDA seeks comments on an information collection extension for “Center for Devices and Radiological Health Appeals Processes.” 03/08/2019
New Info Collection on Bio Product Name Suffix
Federal Register notice: FDA seeks comments on a new information collection for “Proposed Suffix for the Proper Name of a Biological Product.” 03/08/2019
Draft Guide on Biologic Product Nonproprietary Naming
Federal Register notice: FDA makes available a draft guidance entitled “Nonproprietary Naming of Biological Products: Update.” 03/08/2019
Panel to Discuss Testosterone Replacement Therapy Development
Federal Register notice: FDA announces a 4/8 Pediatric Advisory Committee meeting to discuss drug development for testosterone replacement therapy in male adolescents. 3/07/2019
510(k) Exemption Proposed for Flow Cytometer Instruments
Federal Register notice: FDA seeks comments on its announced intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. 03/06/2019
Software Apps for Contraception Placed into Class 2
Federal Register notice: FDA classifies software applications for contraception into Class 2 (special controls). 03/06/2019
Comments Sought on Info Collection for IVD Study Guide
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable.”03/05/2019