Latest Federal Register Notices

Doryx Not Withdrawn Due to Safety/Effectiveness: FDA
Federal Register notice: FDA determines that Mayne Pharma International’s Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn from sale for safety or effectiveness reasons. 03/09/2018

Advisory Committee Docket Number Corrected
Federal Register notice correction: FDA corrects a 2/22 notice entitled “Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting.” 03/08/2018

Class 2 for Extracorporeal Shock Wave Device
Federal Register notice: FDA classifies the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls). 03/07/2018

Comments Sought on Device Reclassification Info Collection
Federal Register notice: FDA seeks comments on an information collection for “Reclassification Petitions for Medical Devices — 21 CFR Section 860.123” (OMB Control Number 0910-0138). 03/07/2018

Draft Guide on Drug Supply Definitions
Federal Register notice: FDA makes available a draft guidance entitled “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.” 03/05/2018

Comments Sought on Pediatric Drug Safety Reviews
Federal Register notice: FDA seeks comments on post-marketing pediatric-focused safety reviews of products posted between 10/23/2017 and 3/16 on its Web site. 03/05/2018