FDA approves an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorouracil, and leucovorin f...
Federal Register notice: FDA issues an order debarring Ross Lucien for five years from importing any drug into the U.S.
Federal Register notice: FDA issues an order to permanently debar Kalpen D. Patel from providing services in any capacity to a person that has an appr...
Federal Register notice: FDA releases a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.
FDA warns Miami, FL-based US Chem Labs and Bronx, NY-based Helix Chemical that they are selling unapproved and misbranded versions of the popular bran...
FDA publishes an ICH draft guideline on post-approval safety data that is available for comment.
FDA clears a Nanox AI 510(k) for HealthFLD, an artificial intelligence software that provides automated qualitative and quantitative analysis of liver...
Former FDAer Naomi Schwartz says medical device companies must prioritize cybersecurity compliance to meet a stricter FDA enforcement emphasis.
