Drugs

Drug Development, FDA Review and Approval

To introduce a new drug product into the U.S. market, some companies develop drugs and submit a new drug application (NDA). It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective to the FDA’s Center for Drug Evaluation and Research (CDER).

The FDA/CDER’s mission is to ensure that drugs marketed in the US are safe and effective.  CDER does not test drugs, although the Center’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.

CDER is the largest of FDA’s five centers. It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs.

A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor’s NDA containing the data and proposed labeling.
The section below entitled From Fish to Pharmacies: The Story of a Drug’s Development, illustrates how a drug sponsor can work with FDA’s regulations and guidance information to bring a new drug to market under the NDA process.

• Learn more from How Drugs are Developed and Approved

Drug Approval Application Types

• Investigational New Drug (IND) Application at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm
  • Content and Format of Phase I IND
  • FDA Guidance on Development Safety Update Report (DSUR)
    • http://www.fda.gov/downloads/Drugs/Guidances/ucm073109.pdf
  • To read 21 CFR Part 312 Investigational New Drug Application (IND)
• New Drug Application (NDA)
  • http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm
• Abbreviated New Drug Application (ANDA): Generics
  • http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm
• Therapeutic Biologic Applications (BLA)
  • http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/default.htm
• Drug Applications for Over-the-Counter (OTC) Drugs
  • http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/Over-the-CounterDrugs/default.htm

Our Consulting Services on Drugs

Our consulting services on drugs include, but are not limited to, strategic guidance and advice during conceptualization, research and development and regulatory submissions and approval.

Helping to Develop Your Practical, Actionable and Sustainable Strategy (PASS).

Development & Approval Process (Drugs)

• How Drugs are Developed and Approved
• Drug and Biologic Approval Reports
• NDA and BLA Approvals
• NME Drug and New Biologic Approvals
• ANDA (Generic) Drug Approvals
• Priority NDA and BLA Approvals
• Efficacy Supplement Approvals
• Accelerated and Restricted Approvals
• NDA Approvals by Therapeutic Potential and Chemical Type
• Fast Track Approval Reports
• Orphan Drug Designation

Good Drug Review Practices

• General / Review Management
  • Good Review Management Principles and Practices for PDUFA Products
• Biometrics
  • Statistical Review Template MAPP 6010.4 
  • Biostatistics New Drug Application Review Template
• Chemistry, Manufacturing and Controls
• Clinical
  • Conducting a Clinical Safety Review of a New Product Application and Preparing a Report  on the Review
    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072974.pdf 
  • Clinical Review Template [downloadable below in PDF] 
  • NDA Filing Review Issues
    • http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM081990.pdf 
  • Premarket Risk Assessment
    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072002.pdf 
  • Evaluating the Risks of Drug Exposure in Human Pregnancies
• Clinical Pharmacology
  • Clinical Pharmacology and Biopharmaceutics NDA Review Template
  • Exposure Response Relationships- Study Design, Data Analysis and Regulatory Applications
    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072109.pdf 
  • Integration of Study Results to Assess Concerns About Human Reproductive and Developmental Toxicities
• Pharmacology/Toxicology
  • Pharmacology/Toxicology Review Format
    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072976.pdf

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Last Updated: 2015-09-25