Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.
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FDA recommends that ingestible fluoride drug products – typically available as tablets and drops – should be limited to children aged three years and older who are at high risk for tooth decay.eCTD Submission Standards for eCTD v3.2.2 and Regional M1
eCTD Submission StandardsAfrica Imports Issues Voluntary Recall of Organic Moringa Leaf Powder Due to Potential Salmonella Contamination
Africa Imports is voluntarily recalling its Organic Moringa Leaf Powder (1 kilogram box) because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, the elderly, and individuals with weakened immune systems. Healthy persons infNewly Added Guidance Documents
Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months.FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary
FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary
