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NDAs & ANDAs
Collected and updated throughout the day to keep you informed. Come back often!
CDER Guidance Documents
NDAs, ANDAs & BLAs- New Originals & Supplements
Drug Safety-Related Label Changes
Thanks for stopping by! We are still working here!
Here are some possibles already proposed:
- Determination of Regulatory Review Period for Purposes of Patent Extension
- Product-Specific Guidance
- Pediatric Exclusivity
- Postmarket Studies
- Withdrawn Drugs
- Off-patent drug
- Accelerated Reviews
- FDA Meetings Schedule
- Advisory Committee Meetings and Results
- Drug Safety Communications
Give us suggestions for what you would want to see. Add some comments below.
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