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Laws & Procedures

• Laws Enforced by the FDA and Related Statutes
• FDA Modernization Act
• Submitting Applications for New Drug Products Information on product applications, electronic submissions, review, and signatures, forms, IND help, investigator lists, and other drug product information
• CDER Manual of Policies & Procedures (MaPP)
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Regulatory Topics

• Guidance Documents from CDER
• FDA Dockets Management
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• CDER Data Standards Manual
• Suitability Petitions  

Compliance Activities

• Disqualified/Restricted/Assurance List for Clinical Investigators This list contains the names of all investigators who have at one time been disqualified, restricted, or have made assurances in their use of investigational products.
• Drug Application Regulatory Compliance
• Drug Registration and Listing
  • Drug Firm Annual Registration Status
• Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations
• Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Specific Initiatives

• Critical Path
• Drug Safety
• Prescription Drug User Fee Act (PDUFA)
• Prescription Drug Marketing Act (PDMA)
• Drugs Marketed in the United States That Do Not Have Required FDA Approval
• FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products
• Final Rule on the Requirements for Prescribing Information for Drug and Biological Products
• Genomics at FDA
• Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach
• Pediatric Drug Development

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