Data Standards in the Drug Lifecycle

• All See All the Data Standards
• E eCTD - Electronic Common Technical Document
• SE SEND - Standard for Exchange of Nonclinical Data
• SD SDTM - Study Data Tabulation Model
• A ADaM - Analysis Data Model
• PQ PQ/CMC - Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (Guidance forthcoming)
• SP SPL - Structured Product Labeling
• I ICSR - Individual Case Safety Report
• U UNII - Unique Ingredient Identifiers
• N NDC/MPID - National Drug Code, Medicinal Product Identifiers

All Active/Applicable Inactive/Not Applicable reset

Discovery
Phase

1. New drug discovered
2. Animal Testing
   1. SE
3. Investigational New Drug (IND) Review
   1. E
   2. SE
   3. SD
   4. A
4. FDA Compliance Inspections throughout the process

   1. SE
   2. SD
   3. PQ

Investigational
Phase

1. Phase I Clinical Trials
   1. SD
   2. A
2. Phase II Clinical Trials
   1. SD
   2. A
3. End of Phase II Meeting
   1. SD
   2. A
4. Phase III Clinical Trials
   1. SD
   2. A
5. Pre-New Drug Application (NDA) Meeting
   1. SE
   2. SD
   3. A
6. FDA Compliance Inspections throughout the process

   1. SE
   2. SD
   3. PQ

Application
Review Phase

1. New Drug Application (NDA)/Biologic License Application (BLA)
   1. E
   2. SE
   3. SD
   4. A
2. FDA Review
   1. SE
   2. SD
   3. A
   4. PQ
   5. SP
   6. U
   7. N
3. Advisory Meetings
4. FDA Approval
   1. SP
   2. N

5. ---

6. Abbreviated New Drug Application (ANDA) for generic versions
   1. E
7. FDA Review
   1. SD
   2. PQ
   3. SP
8. FDA Approval
   1. SP
   2. N
9. FDA Compliance Inspections throughout the process

   1. SE
   2. SD
   3. PQ

Post-Market
Surveillance

1. Safety Oversight
   1. E
   2. SP
   3. I
2. Drug Quality Oversight
   1. E
   2. PQ
3. Drug Promotion Oversight
   1. E
4. Compliance
   1. PQ
   2. SP
   3. N
5. Supplemental NDAs/BLAs
   1. E
   2. SD
   3. A
   
   
   4. SP
   5. U
   6. N
6. 
7. Over-the-counter (OTC) Drugs
8. 
9. FDA Compliance Inspections throughout the process

   1. SE
   2. SD
   3. PQ

Supplemental NDAs/BLAs

Supplemental NDAs/BLAs may be submitted to change the composition of an approved drug or add a new indication. Depending on the type of change, a supplement may enter the drug lifecycle at one of these points:

1. Investigational Phase, with additional Phase III clinical trials
2. Application Review Phase, with the submission of a supplemental NDA/BLA

Over-the-Counter (OTC) Drugs

A new OTC drug may be approved through

1. The same process as a new prescription drug,
2. A New Drug Application (NDA) or an efficacy supplement submitted for an existing drug, or
3. Compliance with a published OTC drug monograph.

FDA Compliance Inspections throughout the process

1. SE
2. SD
3. PQ

Supplemental NDAs/BLAs

Supplemental NDAs/BLAs may be submitted to change the composition of an approved drug or add a new indication. Depending on the type of change, a supplement may enter the drug lifecycle at one of these points:

1. Investigational Phase, with additional Phase III clinical trials
2. Application Review Phase, with the submission of a supplemental NDA/BLA

Over-the-Counter (OTC) Drugs

A new OTC drug may be approved through

1. The same process as a new prescription drug,
2. A New Drug Application (NDA) or an efficacy supplement submitted for an existing drug, or
3. Compliance with a published OTC drug monograph.

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Page Last Updated: 12/12/2016