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Regulatory Approval

Regulatory Approval: If a compound successfully completes clinical trials and demonstrates safety and efficacy, it can be submitted for regulatory approval to market the drug.   Regulatory approval is a crucial step in drugdiscovery and development. It involves the process by which a drug candidate is assessed and approved by regulatory authorities (such as the FDA in the United States, EMA in Europe, or similar agencies in other countries) before it can be marketed and sold to the public. Here’s an overview of the regulatory approval process in drug discovery:
    Preclinical Research
    Investigational New Drug (IND) Application
    Clinical Trials: 

  •     Phase 1: Initial trials in a small group of healthy volunteers to assess safety and dosage.
  •     Phase 2: Trials in a larger group of patients with the di
  •     Phase 3: Large-scale trials to confirm efficacy, monitor side effects, and compare the new drug to existing treatments.
  •     New Drug Application (NDA).
     
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