Latest Federal Register Notices
SUNSET Rule Effective Date Postponed
03/19/2021 Federal Register notice: HHS is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/22. However, on 3/9 a lawsuit was filed seeking to overturn the final rule, and HHS has decided to postpone it during the judicial review. Under the rule as proposed, subject to certain exceptions, HHS regulations would expire at the end of (1) two calendar years after the year that the SUNSET rule first became effective, (2) ten calendar years after the year of the regulation’s promulgation, or (3) ten calendar years after the last year in which the Department “assessed” and, if required, “reviewed” the regulation, whichever was latest. In addition, the final rule contains exemptions for a small set of certain FDA regulations. To view the notice, click here.
Animal Drug Regs Amended on Review Actions
03/18/2021 Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July, August, and September 2020. FDA is also making available summaries of the basis of approval and environmental review documents, where applicable. To view the notice, click here.
Comments Reopened on Orange Book Listings
03/17/2021 Federal Register notice: FDA is reopening the comment period for a 6/1/2020 notice entitled “Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments.” Electronic or written comments should be submitted by 4/15. To view the notice, click here.
FDA Withdraws Approval of 19 ‘Not Marketed’ NDAs
03/17/2021 Federal Register notice : FDA is withdrawing approval of 19 NDAs from multiple applicants after they notified the agency that the drugs were no longer marketed and requested their withdrawal. To view the notice, click here.
Nipride Not Withdrawn Due to Safety/Efficacy: FDA
03/17/2021 Federal Register notice: FDA has determined that Exela Pharma Sciences’ Nipride RTU (sodium nitroprusside), 10mg/50mL, was not withdrawn from sale for safety or effectiveness. The determination will allow FDA to approve ANDAs for sodium nitroprusside if all other legal and regulatory requirements are met. The drug is indicated for immediate blood pressure reduction in adult and pediatric patients in hypertensive crises; induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding; and treatment of acute heart failure to reduce left ventricular end- diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance, and mean arterial blood pressure. To view the notice, click here.
Review Period Determined on Lung Donor Device
03/16/2021 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for TransMedics’ OCS Lung System, indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double-lung transplantation. The review period was determined to be 2,341 days, which includes 1,672 days that occurred during the testing phase and 669 days during the approval phase. To view the notice, click here.