Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Luis Solera Blasco Recipient Title Chief Executive Officer Bioiberica, SAU Plaza Francesc Macia, 708029 Barcelona BarcelonaSpain […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER January 16, 2025 RE: 698165 Dear Michael […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Pardeep K. Gupta ProRx, LLC 619 Jeffers CircleExton, PA 19341-2540United […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-25-31 Product: Drugs Recipient: Recipient Name Ms. Sezin Zavaro Recipient Title Head of […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-01-01 Product: Drugs Recipient: Americo F. Padilla, M.D./Miami Dade Medical Research Institute 8955 Southwest 87th […]

Summary Company Announcement Date: January 24, 2025 FDA Publish Date: January 24, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) […]

[Posted 01/22/2025] AUDIENCE: Patient, Caregiver, Health Care Professional, Pharmacy, Neurology ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with […]

NCTR’s annual report summarizes the key accomplishments for each research division for the reported year. The report includes ongoing research project information, research collaboration highlights, and […]