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Data Standards in the Drug Lifecycle

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FDA Compliance Inspections throughout the process
  1. SE
  2. SD
  3. PQ

More information iconSupplemental 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

More information iconOver-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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