Human Drugs
Travere Therapeutics NDA Accepted for Sparsentan
FDA accepts for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy.
Federal Register
Howard Head Debarred for 5 Years
Federal Register notice: FDA debars for five years Howard Stanley Head from importing or offering for import any drug into the U.S.
Human Drugs
Final Guide on Investigating Out-of-spec Results
FDA posts a final guidance entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
Medical Devices
Avanos Recalls Cortrak 2 Enteral Access Device
Avanos Medical recalls (Class 1) its Cortrak 2 Enteral Access System due to reports of injuries and patient deaths after nasoenteric or nasogastric tu...
Medical Devices
New Home Covid Test Gives Results for Flu, RSV too
FDA issues an Emergency Use Authorization (EUA) for the Labcorps Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respirato...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 5/13/2022.
Human Drugs
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 5/13/2022.
Human Drugs
Nature Examines Potential Accelerated Approval Reforms
The journal Nature examines the problems with FDAs accelerated approval program and potential reforms to reduce any gaming by the pharmaceutical indus...
Federal Register
HIV Tests Down Classified to 510(k)
Federal Register notice: FDA issues a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tes...
