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Drugs
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Small Business Assistance
What's New for Small Pharmaceutical Businesses: Sign up for an E-mail notification to receive new information (Federal Register notices, guidances, etc.) from Small Business Assistance in CDER. |
- General Information on Small Business Assistance
- Information for Clinical Investigators
- New Drug Development and Review Process
- Therapeutic Biological Products
- Frequently Asked Questions About Therapeutic Biological Products
- Orphan Drug Program
- Generic Drug Review Process
- Over-the-Counter Drug Product Review Process
- Post Drug-Approval Activities
- Import and Export of Human Drugs and Biologics
- Drug Registration and Listing
- Organization, Contact, and Meeting Information
- FDA Related Laws, Regulations, and Guidances
- Economic Assistance and Incentives for Drug Development
- Workshops
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