Latest Federal Register Notices
Guide on Nicotine Delivery System Enforcement
Federal Register notice: FDA makes available a final guidance entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).” 10/23/2020
Info Collection on Animal Drugs for Minor Species
Federal Register notice: FDA sends to OMB an information collection extension for “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR Part 516.” 10/22/2020
Device Conformity Assessment Pilot Info
Federal Register notice: FDA sends to OMB a new information collection entitled “Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.” 10/22/2020
Nonclinical Study Data eSubmission Pilot
Federal Register notice: FDA announces that it intends to conduct a fit-for-use pilot program to test the processing and analysis of nonclinical study data submitted electronically. 10/22/2020
28 Drugs Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that 28 drug products listed in the notice were not withdrawn from sale for safety or effectiveness reasons. 10/21/2020