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

Preclinical Studies: This is the first step in the drug approval process, involving pharmacological and toxicological studies to assess the drug's safety and efficacy. These studies are usually conducted in laboratories or animal models. 

Submission of an Investigational New Drug Application (IND): Once preclinical studies indicate that the drug might be safe, pharmaceutical companies submit an Investigational New Drug application (IND). The IND includes preclinical study data, manufacturing information, and clinical trial protocols. 

Clinical Trials: This is the core part of the drug approval process and mainly consists of three phases. Phase I primarily tests the drug's safety and dosage in humans; Phase II focuses on the drug’s efficacy and side effects; Phase III further confirms efficacy, monitors side effects, and compares the drug with existing treatments.

Submission of a New Drug Application (NDA): If clinical trials yield positive results, pharmaceutical companies submit a New Drug Application (NDA). The NDA includes clinical trial data, drug ingredients and formulations, manufacturing processes, sample labels, and recommendations for drug use.

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

Post-Market Regulation: Once the drug is on the market, the FDA continues post-market regulation, including monitoring the drug's safety and effectiveness and overseeing the pharmaceutical company’s manufacturing and distribution activities. 

This is a general overview of the process; specific cases may vary.