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New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)

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Vamsikrishna Reddy
Vamsikrishna Reddy

It describes the NDA and ANDA repuirements for FDA approval and differences between them

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New Drug Application(NDA) Vs Abbreviated new drug application (ANDA) ,[object Object],[object Object],[object Object],[object Object],Name: Sneya Priya Year : M.Pharm( Pharmaceutics) College: Manipal college of Pharmaceutical Scieces(MCOPS), Manipal Email id: snehpriya123@gmail.com
Contents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New Drug Application ,[object Object],[object Object],[object Object],[object Object],[object Object]
NDA Classifications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New Drug Development and Review Process Steps from Test Tube to New Drug Application Review
Phases of clinical testing Phase Number of patients Length Purpose Percent successfully completing Phase1 20-100 Several months Mainly safety 67 Phase2 Up to several hundred Several months to two years Some short-term safety but mainly effectiveness 45 Phase3 Several hundred to several thousand 1-4 years Safety, effectiveness, dosage 5-10
NDA Review Process
NDA CONTENTS ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The NDA in CTD Format Module 1 is not part of the CTD because it is not harmonized CTD NDA: 314.50 Module 1 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Module 2 c)Summaries d)5.7 Abuse potential Module 3 d)1 CMC Module 4 d)2 Nonclinical pharm/tox Module d)3 Human PK d)4 Microbiology d)5 Clinical data d)6 Statistical section f) CRF and CRT
ANDA   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Goal of ANDA ,[object Object],[object Object],[object Object]
ANDA Review process
NDA vs. ANDA Review Process ,[object Object],[object Object]
What is Bioequivalence? ,[object Object],[object Object],[object Object]
Patent Certification condition for ANDA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Paragraph IV certification ,[object Object],[object Object],[object Object],[object Object]
Patent Challenge Successful – Award of 180-Day Exclusivity Period ,[object Object],[object Object],[object Object],[object Object],[object Object]
Orphan Drug Exclusivity (ODE) ,[object Object],[object Object],[object Object],[object Object]
ANDA approval status
CONCLUSION NDA ANDA Applicable for new drug Applicable for generic drug Take longer time ( 12-15 years) Compare to NAD less time taken(1-2 years) More expenditure of money Comparatively less Cost of drugs are more Cost of drugs are less Nonclinical studies and clinical investigations are essential Nonclinical studies and clinical investigations are nonessential except bioavailability and bioequivalence
REFERENCES ,[object Object],[object Object],[object Object],[object Object]
[object Object]

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New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)

  • 1.
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  • 3.
  • 4.
  • 5. New Drug Development and Review Process Steps from Test Tube to New Drug Application Review
  • 6. Phases of clinical testing Phase Number of patients Length Purpose Percent successfully completing Phase1 20-100 Several months Mainly safety 67 Phase2 Up to several hundred Several months to two years Some short-term safety but mainly effectiveness 45 Phase3 Several hundred to several thousand 1-4 years Safety, effectiveness, dosage 5-10
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  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
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  • 17.
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  • 19.
  • 20.
  • 21.
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  • 25.
  • 26.
  • 27.
  • 28.
  • 30. CONCLUSION NDA ANDA Applicable for new drug Applicable for generic drug Take longer time ( 12-15 years) Compare to NAD less time taken(1-2 years) More expenditure of money Comparatively less Cost of drugs are more Cost of drugs are less Nonclinical studies and clinical investigations are essential Nonclinical studies and clinical investigations are nonessential except bioavailability and bioequivalence
  • 31.
  • 32.