Federal Register notice: FDA makes available a final guidance entitled Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria.
Federal Register notice: FDA determines that Norflex (orphenadrine citrate) injection and extended-release tablets were not withdrawn from sale for re...
FDA releases the form FDA-483 with 10 observations from an inspection at the Telangana, India-based Aurobindo Pharma Unit IX active pharmaceutical ing...
The FDA Digital Health Center of Excellence publishes a 2022 report on non-device software functions.
FDA publishes a draft guidance to further explain but not change the Voluntary Malfunction Summary Program.
FDA releases the form FDA-483 with 16 observations from an inspection at the Pradesh, India-based Lupin Unit 1 drug manufacturing facility.
FDA publishes a proposed rule to make the investigational new drug annual reports more comprehensive and similar to those in other countries.
FDA publishes a draft guidance on the content of human factor and usability engineering information to be included in medical device marketing submiss...
