Summary Company Announcement Date: July 22, 2024 FDA Publish Date: July 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Drug Ingredients: Diclofenac […]
Summary Company Announcement Date: July 22, 2024 FDA Publish Date: July 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of Dexmedetomidine […]
Who We Are The Division of Pediatrics and Maternal Health (DPMH) is located in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM). DPMH is […]
Background FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide—”Patient Medication Information” (PMI)—for prescription drug products […]
Aruba Aloe Balm Inc. (Aruba) Aruba Aloe Hand Sanitizer 80% Alcohol 53675-185-1253675-192-02 Aruba Aloe of North America LLC (Indiana) Product contains methanol based on information provided […]
Submit Comments by 09/17/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
Docket Number: FDA-2022-D-0113 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting […]
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