Drugs
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Resources for You
Center for Drug Evaluation and Research Organization Division of Drug Information (DDI) Electronic Regulatory Submission and Review European Medicines Agency Small and Medium Sized Enterprises office (SME office) 
FDA Related Laws, Regulations, and Guidances - Pre-IND Meeting Frequently Asked Questions
Pre-IND Consultation Program - Small Business Assistance Contact, Organization, and Meeting Information
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Small Business Assistance
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
For easier access to CDER Small Business Assistance download our widget
Small pharmaceutical business is integral in bringing innovative medical products to the U.S. marketplace. The purpose of this website is to support the CDER Small Business Assistance Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business seeking timely and accurate information relating to development and regulation of human drug products.
In order to collect valuable information and better improve our services, we ask that you PLEASE TAKE OUR SHORT SURVEY . Please complete the survey only once.
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Drug Review Process
- Addresses for CDER Regulatory Submissions
- Generic Drug Review Process
- New Drug Development and Review Process
Process for development of new drugs and therapeutic biologics. 505(b)(2), Meetings with FDA, Drug development costs, Statistics - Over-the-Counter Drug Review Process
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Drug Development
Biosimilars Driving Biomedical Innovation: Initiatives for Improving Products for Patients Drug Master Files (DMFs) Economic Assistance and Incentives for Drug Development FAQs and Common Complaints Generic Drug User Fee Amendments of 2012 - Good Clinical Practice: Running Clinical Trials
- Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
- Orphan Products Development
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