Latest Federal Register Notices
Info Collection Extension Device Recall Authority
Federal Register notice: FDA submits to OMB an information collection extension for “Medical Device Recall Authority” (OMB Control Number 0910-0432). 08/03/2018
Workshop on Advancing Pediatric Pharmacovigilance
Federal Register notice: FDA announces a 9/14 public workshop entitled “Advancing the Development of Pediatric Therapeutics: Advancing Pediatric Pharmacovigilance.” 08/02/2018
Prescription Drug User Fee Rates for FY 2019
Federal Register notice: FDA announces the fiscal year 2019 for prescription drug user fees. 08/01/2018
FY 2019 Drug Compounding Rates
Federal Register notice: FDA announces the fiscal year 2019 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. 08/01/2018
Medical Device User Fees for FY 2019 Set
Federal Register notice: FDA announces the fee rates and payment procedures for medical device user fees for fiscal year 2019. 07/31/2018
Biosimilar User Fee Rates Established
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2019. 07/31/2018
List of Information Collections Approved by OMB
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB under the Paperwork Reduction Act. 07/30/2018
Polyethylene Glycol 3350 Approval Withdrawals Stayed
Federal Register notice: FDA extends until 11/2 the effective date of its order withdrawing approval of ANDAs for the prescription polyethylene glycol 3350. 07/30/2018