Federal Register Notices Week of July 4
FDA Webview has posted the Federal Register notices that published during the week of our annual Fourth of July (Independence Day) holiday break.
7/8/2022
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Astellas Pharma and Seagen’s Padcev (enfortumab vedotin-ejfv), indicated for treating adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death-ligand inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. To view the notice, click here.
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Genentech’s Rozlytrek (entrectinib), indicated for treating certain adult patients with metastatic non-small cell lung cancer, and certain adult and pediatric patients with solid tumors. To view the notice, click here.
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Viela Bio’s Uplizna (inebilizumab-cdon), indicated for treating neuromyelitis optica spectrum disorder in adult patients who are anti- aquaporin-4 antibody positive. To view the notice, click here.
7/7/2022
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Collection of Conflict-of-Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs” (OMB Control Number 0910-0882). To view the notice, click here.
Federal Register notice: FDA has issued an order debarring Jhanna Novikov for five years from importing or offering for import any drug into the U.S. The debarment is based on her conviction over smuggling unapproved Botox (botulinum neurotoxin Type A) into the U.S. To view the notice, click here.
7/6/2022
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Emergency Use Authorization of Medical Products” (OMB Control Number 0910-0595). To view the notice, click here.
Federal Register notice: FDA has announced the renewal of the Pharmacy Compounding Advisory Committee for an additional two years beyond its charter expiration date. The new charter will be in effect until 4/25/2024. To view the notice, click here.
Federal Register notice: FDA is making available a draft guidance entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs.” The document identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. To view the notice, click here.
Federal Register notice: FDA has made available a revised draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” The document explains how to determine when certain statutory requirements will apply to entities that are considered trading partners in the drug supply chain. It also discusses the activities of private-label distributors, salvagers, and returns processors and reverse logistics providers. To view the notice, click here.
Federal Register notice: FDA is seeking industry organizations that are interested in participating in selecting nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee. To view the notice, click here.