FDA Regulatory Calendar.
Key compliance deadlines and regulatory dates for food, drug, device, and cosmetics companies. Never miss a critical deadline.
Key Deadlines
Track every critical FDA compliance date for your product category.
GDUFA User Fees Due
Generic drug establishment user fees for FY2026 become due. Late payment can result in registration issues.
MDUFA User Fees Due
Medical device establishment user fees for FY2026 become due.
GDUFA Annual Facility Fee Payment
Final deadline for GDUFA facility fee payments without penalty.
FSVP Annual Review Due
Annual review of FSVP programs and supplier verification activities. Ensure documentation is current.
MoCRA GMP Regulations Final
FDA expected to finalize Good Manufacturing Practice regulations for cosmetics under MoCRA.
Fragrance Allergen Labeling Rules
FDA to finalize list of fragrance allergens requiring disclosure on cosmetic labels.
Food Facility Biennial Registration Renewal
All registered food facilities must renew their FDA registration during this period. Facilities that don't renew will have their registration cancelled.
Drug Establishment Annual Registration
All drug establishments (domestic and foreign) must renew their FDA registration and update drug listings.
Medical Device Establishment Registration
Device establishments must register annually during this period and pay applicable user fees.
Drug Establishment Annual Registration
Annual drug establishment registration renewal period.
Food Facility Biennial Registration Renewal
Next biennial registration renewal for food facilities.
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