FDA story: What are different phases of drug development from FDA perspective?

FDA story: What are different phases of drug development from FDA perspective?

While working on launch analytics for new products, I encountered terms like IND and NDA related to U.S. Food and Drug Administration (FDA). My curiosity led me to Google them and read up on their meanings. Although this method is effective for learning, a formal approach is even better as it helps you understand these terms within the broader context of the process. After 6-7 months of procrastination, I finally took the formal route today where I have mapped these terms with the drug development lifecycle (Creating this image took me about 4 hours including downtime, during which I read through three different sources and examined multiple images related to drug development.).

> Investigational New Drug (IND): During the discovery and preclinical phase (before Phase 0), Entity / sponsor / pharma company can file an Investigational New Drug (IND) application to the FDA which must include all pertinent information including preclinical data, clinical protocols for studies that will be conducted, manufacturing information, and information regarding the investigator. The FDA review team has 30 days to review the original IND submission. After the FDA approves an IND submitted by a sponsor (i.e. entity developing the drug) clinical trials can begin. 

> New Drug Application (NDA): There are three clinical phase studies that take place before a drug gets approved, with each having its own purpose. 

Once a sponsor has sufficient evidence from preclinical and clinical studies that their drug is safe and effective for its intended use, then after the end of clinical trials stage III, a New Drug Application (NDA) can be filed to the FDA for approval. Proposed labeling, Safety updates, Drug abuse information, 

Patent information, Any data from studies that may have been conducted outside the United States, Institutional review board compliance information, Directions for use is given within an NDA, along with clinical studies data. NDA review team has 6-10 months to decide whether to approve the new drug. 

If FDA approves the product, then fourth phase is carried out, which centers on the products safety and efficacy profile. 

Overall, only about 13.8% of all drug candidates make it from preclinical trials to final approval

"Follow" me for more such stories

Read past stories like above at https://lnkd.in/d9ijze8r