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CBER publishes a standard operating policy and procedure on Section 505 (o)(4) safety labeling changes to drugs approved by NDAs a...[ Price : $8.95]
After 12+ years, FDA accepts a specific labeling change sought for glucocorticosteroids in a Public Citizen 2011 petition, while d...[ Price : $8.95]
FDA clears a Masimo 510(k) for its MightySat Medical, an over-the-counter fingertip pulse oximeter.[ Price : $8.95]
FDA warns New Delhi, India-based Madhu Instruments Private Limited that it is producing drugs in insanitary conditions.[ Price : $8.95]
FDA warns Chinas Ningbo Poplar Daily-Use about CGMP violations in its manufacturing of over-the-counter drugs.[ Price : $8.95]
The FDA Office of Digital Transformation posts its new IT operating plan and its 2023 annual report.[ Price : $8.95]
FDA approves an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorourac...[ Price : $8.95]
Federal Register notice: FDA issues an order debarring Ross Lucien for five years from importing any drug into the U.S.