- Distinguish between the term’s pharmaceutical, biopharmaceutical, biologic, generic, biosimilar, and drug
- Identify the significant milestones in manufacturing a drug; R&D, pre-clinical studies, clinical studies and the application process for new products, & post-market surveillance
- Differentiate between the different drug application review processes: NDA, ANDA, BLA, fast track, OTC, priority, and orphan
- Explore exceptions to the drug review & patent process
- Utilize FDA databases to look up drugs; orange book, clinical trials, drug database
- Demonstrate knowledge of Prescription drug labeling and explain limitations to drug advertising
This chapter provides an in-depth exploration of the regulations and submission requirements for a new drug. The process of bringing a drug out of development and onto the market is very rigorous, time-consuming, and expensive. By some estimates, the process can take upwards of 15 years, and a typical drug company may spend close to $800 million to create a marketable new drug. The biggest hurdle a new drug must overcome is the testing required by the FDA. As previously discussed, prescription drugs are regulated under the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act). Only about 1 in 5000 potential drugs successfully pass through the testing process to be approved by the FDA for patient use. The FDA has an extensive website outlining the drug development process.
- 6.1: Introduction – The Pharmaceutical Product Approval Process
- Before we begin diving into the regulation, it's important to understand standard pharmaceutical manufacturing terminology.
- 6.3: Different Drug Application Review Processes
- If the drug passes all three phases of testing, the company may file a New Drug Application (NDA), which permits the FDA to ascertain that the new drug (or biologic) is safe, reliable, and effective for the indications on the labeling. The FDA employs expert reviewers who examine the test results and determine whether the new drug can be approved.