CBER publishes a standard operating policy and procedure on Section 505 (o)(4) safety labeling changes to drugs approved by NDAs and BLAs.
After 12+ years, FDA accepts a specific labeling change sought for glucocorticosteroids in a Public Citizen 2011 petition, while denying other petitio...
FDA warns New Delhi, India-based Madhu Instruments Private Limited that it is producing drugs in insanitary conditions.
FDA warns Chinas Ningbo Poplar Daily-Use about CGMP violations in its manufacturing of over-the-counter drugs.
The FDA Office of Digital Transformation posts its new IT operating plan and its 2023 annual report.
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...
