FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling. Human prescription drug labeling: Contains a summary of […]

For Immediate Release: March 07, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, […]

Docket Number: FDA-2019-D-1615 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of the Commissioner, Office of […]

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review […]

Delivery Method: Overnight Delivery Product: Dietary SupplementsDrugs Recipient: Recipient Name Robert W. Matheson Berkeley Nutritional Mfg Corp. 1852 Rutan DriveLivermore, CA 94551-7635United States Issuing Office: San […]

Product: Drugs Recipient: Recipient Name Mr. Chris Beekman NutraCore Health Products Nutracore Health Products 1207 Halapa WayTrinity, FL 34638United States Issuing Office: DEPARTMENT OF HEALTH AND […]

Product: Drugs Recipient: Recipient Name Mr. Kenneth Nersten Choice Detox Center, Inc. dba Nofeel Choice Detox Center, Inc. dba Nofeel 552 Hamilton StreetSuite E-1Costa Mesa, CA […]

Delivery Method: UPS NEXT DAY DELIVERY Reference #: 2016-DAL-WL-26 Product: Drugs Recipient: Recipient Name Marshall A. Dunlap Recipient Title Owner Best Bentonite Best Bentonite 11650 Otis […]

Actemra (tocilizumab) Drug reaction with eosinophilia and systemic symptoms FDA is evaluating the need for regulatory action. Aliqopa (copanlisib) Cytomegalovirus infection The “Warnings and Precautions”, “Dosage […]