fda (food and drug administration)

What are the Key Steps in the FDA Approval Process?

The FDA approval process generally involves several key steps:
Preclinical Testing: Laboratory and animal tests to determine if the product is safe for human testing.
Investigational New Drug (IND) Application: Submission of data to the FDA to request permission to start human trials.
Clinical Trials: Conducting human trials in phases to test safety and efficacy.
New Drug Application (NDA) or Premarket Approval (PMA): Submission of all data from trials for FDA review.
FDA Review: FDA scientists review the data and make a decision.
Post-Market Surveillance: Ongoing monitoring of the product once it is on the market.

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