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Latest posts
Last updated about 11 hours ago
Compounding: Inspections, Recalls, and other Actions
about 11 hours ago
Human drug compounding; FDA inspections; compounding recalls
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format
about 13 hours ago
Labeling
Quarterly Inactive Ingredient Database (IID) Change Log
about 13 hours ago
Quarterly IID Change Log displays changes made since the previous quarterly IID...
E2F Development Safety Update Report
about 13 hours ago
International Council on Harmonisation - Efficacy
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
about 14 hours ago
Clinical/Medical
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
about 17 hours ago
Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug...
Environmental Assessment of Human Drug and Biologics Applications
about 18 hours ago
Pharmaceutical Quality/CMC
Fagron Compounding Services, LLC dba Fagron Sterile Service - 698861 - 12/19/2024
about 19 hours ago
Compounding Pharmacy/Adulterated Drug Products
Global Calcium Pvt. Limited - 692000 - 01/16/2025
about 19 hours ago
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Imperial Palace Commodity -Dongguan- Co., Ltd. - 692842 - 01/27/2025
about 19 hours ago
CGMP/Finished Pharmaceuticals/Adulterated
Shantou Kangjie Daily Chemical Industry Co., Ltd - 698223 - 01/28/2025
about 19 hours ago
CGMP/Finished Pharmaceuticals/Adulterated