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Last updated 2 days ago
Newly Added Guidance Documents
2 days ago
Guidance documents represent the FDA's current thinking on a particular subject. New...
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
2 days ago
The U.S. Food and Drug Administration today announced it is taking action...
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates
2 days ago
This guidance describes the FDA’s regulatory and enforcement priorities regarding the compounding...
FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer
2 days ago
On September 4, 2026, the Food and Drug Administration granted accelerated approval...
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
2 days ago
The U.S. Food and Drug Administration today expanded treatment options for adult...
ZUBB Dietary Supplement may be harmful due to hidden ingredient
2 days ago
The Food and Drug Administration is advising consumers not to purchase or...
Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
2 days ago
This webpage provides links to certain publicly available external reports and resources...
GDUFA Type II API DMF Payment Receipts Report
2 days ago
GDUFA Type II API DMF Payment Receipts Report
FDA Approves First Drug to Treat Alexander Disease
3 days ago
The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for...
FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
3 days ago
The U.S. Food and Drug Administration today issued an Emergency Use Authorization...