Drug development and approval process

Template

The drug development process is regulated by the FDA’s high quality standards. With the Pipefy’s template it is possible intuitively and in an organized manner to follow the workflow through development and approval.

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Template structure

See how this template is structured. As this is just an example, you can customize it.

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  • 1. Drug name

  • 2. Drug category

    • Antipyretics
    • Analgesics
    • Antimalarial drugs
    • Antibiotics
    • Antiseptics
    • Mood stabilizers
    • Hormone replacements
    • Oral contraceptives
    • Stimulants
    • Tranquilizers
    • Statins
  • 3. Development type

    • APIs
    • Generic drug
    • Patented drug
    • CRAM (contract research and manufacturing services)
  • 4. Responsible team

  • 5. Due date

Discovery and development

  • 1. How is the drug absorbed, distributed, metabolized, and excreted?

  • 2. Potential benefits

  • 3. Best dosage

  • 4. Most suitable way to administer the drug

    • Oral route
    • Injection route
    • Rectal route
    • Other
  • 5. Effectiveness compared to similar drugs

  • 6. Attachments

Preclinical research

  • 1. Test date

  • 2. Study reports

  • 3. Operating procedure

  • 4. Testing material

    • Saliva
    • Urine
    • Blood
    • Feces

Clinical research

  • 1. Who qualifies to participate

  • 2. Number of participants

  • 3. Study duration

  • 4. Will there be a control group or other ways to limit research bias?

    • Yes
    • No
  • 5. Dosage given to the patients

  • 6. Methodology used to analyze the data

  • 7. IND application

FDA review

  • 1. Patent information

  • 2. Drug abuse information

  • 3. Directions of use

  • 4. Safety updates

FDA post-market safety monitoring

  • 1. Checklist

    • Manufacture inspection
    • Premarket approval
    • Humanitarian device exemption
    • Product development protocol
  • 2. Final report

Done

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