LAXAI

“Aiding Discovery, Enhancing Life”

Regulatory  bodies  and  processes

HYDERABAD – INDIA, NEW JERSEY -USA

www.laxai.com

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Basic Disciplines of Drug Development

Clinical  Trials
Preclinical  
Phase  I Phase  II Phase  III FDA Phase  IV
Testing

12  
Years 3.5 1 2 3 2.5
Total

Laboratory   20  to  80   100  to  300   1000  to  3000  

Test  
and  animal   File   healthy   patient   patient   File  
Population Additional  
studies IND   volunteers volunteers volunteers NDA   Post  
at   at   Review   marketing  
FDA Verify   FDA process  /   testing  
Assess   Evaluate   effectiveness,  
Determine   Approval required  by  
safety  and   effectiveness,   monitor  
Purpose safety  and   FDA
biological   look  for  side   adverse  
dosage
activity effects reactions  from  
long-­‐‑term  use

5,000  
Success   1  
compound 5  enter  trials
Rate approved
s  evaluated

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Organization of the FDA

§ Center  for  Drug  Evaluation  and  Research  (CDER)

§ Center  for  Biologics   Evaluation  and  Research  (CBER)
§ Center  for  Devices  and  Radiological  Health  (CDRH)

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Basic Disciplines of Drug Development

§ Clinical  Investigation
ü Submission  of  the  IND
ü Conduct  of  Clinical  Studies
• Phase  1
• Phase  2
• Phase  3
• Phase  4  (post-­‐‑marketing  studies)

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Basic Disciplines of Drug Development
§ IND  Submission
ü request  for  permission  from  FDA  to  begin  testing  the  product  in  humans
ü Compilation  of  the  following:
• Data  obtained  during  nonclinical   investigation  stage  and  from  previous  
human  experience
• Chemistry,  manufacturing,  and  control  data
• Protocol
• Detailed  description  of  proposed  studies
ü 30-­‐‑day  review  period  at  FDA

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IND Review Process

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Basic Disciplines of Drug Development
§ Clinical  Studies
ü Conducted  in  healthy  volunteers  or  in  patients
ü Three  phases  (1-­‐‑3)  during  this  stage  of  development  and  one  phase  (4)  
following  marketing  approval
ü Takes  an  average  of  6  years  to  complete  the  first  three  stages

• Phase  1  Clinical  Studies

• Phase  2  Clinical  Studies

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Meeting with FDA (End – of – Phase 2)
§ End-­‐‑of-­‐‑Phase  2  Meeting
ü Proposed  Phase  3  adequate  and  well-­‐‑controlled  study  design  and  
analysis  plan
ü Obtain  agreement  from  FDA  on  Phase  3  adequate  and  well-­‐‑controlled  
study  design  and  analysis  plan

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Basic Disciplines of Drug Development

§ Phase  3  Clinical  Studies

§ Marketing  Applications
ü NDA,  sNDA,  ANDA  for  drugs
• NDA  – New  Drug  Application
• sNDA  – supplemental  New  Drug  Application
• ANDA  -­‐‑ Abbreviated  New  Drug  Application  
§ Drugs:  New  Drug  Application  (NDA)
ü 80%  of  an  NDA  is  clinical  data
ü Includes  the  following:
• Results  of  animal  and  clinical  studies
• Any  foreign  clinical  and  marketing  data
• Detailed  chemistry,  manufacturing,  and  control  data

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NDA Approval Process

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Basic Disciplines of Drug Development

§ Phase  4  Clinical  Studies

ü Conducted  after  approval  to  market  has  been  granted  by  FDA
ü Designed  to  confirm  the  safety  of  the  product  in  large  patient  
populations
ü Involve  AE  reporting  by  physicians

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Links to Web

§ The  U.S.  Drug  Approval  Process:  A  Primer  

http://www.thememoryhole.org/crs/more-­‐‑reports/RL30989.pdf

§ The  New  Drug  Development  Process  

http://www.fda.gov/cder/handbook/develop.htm

§ Content  and  Format  of  INDs  for  Phase  1  Studies  of  Drugs  
http://www.fda.gov/cder/guidance/clin2.pdf

§ Center  for  Devices  and  Radiological  Health  

http://www.fda.gov/cdrh/

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Discussion

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