The FDA drug approval process is both standardized and rigorous. Here's a detailed breakdown of the entire process:

1.Preclinical Research: This is the first step in the drug approval process. It includes pharmacological and toxicological studies to evaluate the safety and effectiveness of the drug. These studies are usually conducted in laboratories or on animal models.

2.Submission of Investigational New Drug (IND) Application: Once the data from preclinical studies suggest that the drug might be safe, the pharmaceutical company submits an Investigational New Drug (IND) application. The IND contains data from preclinical studies, manufacturing information, clinical trial protocols, and more.

3.Clinical Trials: This is the heart of the drug approval process and it typically encompasses three phases. Phase I primarily tests the drug's safety and dosage in humans. Phase II focuses on its effectiveness and side effects. Phase III further verifies its effectiveness, monitors side effects, and compares it to existing treatments in terms of benefits and risks.

4.Submission of New Drug Application (NDA): If the results from clinical trials are positive, the pharmaceutical company will submit a New Drug Application (NDA). The NDA includes clinical trial data, details about the drug's ingredients and dosage form, manufacturing processes, sample labels, and suggestions for use.

5.FDA Review: The FDA reviews the NDA, which involves a thorough analysis of the provided data and inspections of manufacturing facilities. If everything meets the criteria, the FDA will approve the drug for marketing.

6.Post-marketing Surveillance: Once the drug is on the market, the FDA continues post-marketing surveillance. This includes monitoring the safety and effectiveness of the drug, and the manufacturing and distribution activities of the pharmaceutical company.

This is a general overview, and specific circumstances might require a more detailed analysis.