The directory comprises of important links in the pharma domain pertaining to the U.S. Region, for your reference.
US Food &Drug Administration
- US Food & Drug Administration Website
- CFR – Code of Federal Regulations Title 21
- Electronic Code of Federal Regulations
- Regulations (publications & Commenting)
- Federal Register
CDER – Human Drugs
- CDER – Human Drugs Website
- CDERLearn Training and Education
- News & Events
- What’s New
- Warning Letters
- Drugs@FDA
- Orange Book
CDER GUIDANCE
- Guidance, Compliance, & Regulatory Information
- Guidance (Drugs)
- Guidance related to Generics
- FDA Regulatory Information
- CGMP for Drugs
- Q&A on CGMPs
- Pharmaceutical Quality Resources
- CDER Science & Research
- CDER’s Science and Research Programs Infographic
- CDER Information for Industry
- CDER Manual of Policies and Procedures (MAPP)
- CDER FOIA (FDA483s)
- Data Standards in the Drug Life Cycle Link 1
- Data Standards in the Drug Life Cycle Link 2
SBIA – Small Business & Industry Assistance
GDUFA – Generic Drug User Fee
- GDUFA
- Generic Drug User Fee Amendments Implementation Activities
- Submission Review
- Drug Master File (DMF) Review Enhancements
- National Drug Code Directory search (NDC)
- DMF Available For Reference list
- Drug Master Files (DMFs)
- Generic Drug Facilities, Sites and Organization Lists
- GDUFA Presentations & Speeches
- GDUFA II Videos & Resources
FDA DASHBOARD
- FDA Data Dashboard Link 1
- FDA Data Dashboard Link 2
- FSMA Data Search & Information
- Compliance Dashboard
- Inspection References
- Inspection Citation
- Inspection Classification Database
- Inspection Observations
Electronic Submissions
- Electronic Submissions Gateway (ESG)
- Guidance – Electronic Submissions
- Electronic Regulatory Submission & Review to CDER
- Electronic Common Technical Document (eCTD)
- Electronic Regulatory Submissions and Review Helpful Links
Office of Generic Drugs (OGD)
- Office of Generic Drugs (OGD)
- Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance
- Generic Drug Review Dashboard Report
- Generic Drugs: Questions & Answers
- Generic Drugs
- Generic Drug Development
- Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
Office of Pharmaceutical Science (OPS)
Office of Regulatory Affairs (ORA)