When it comes to modern medicine, the development of prescription drugs for various diseases and conditions becomes more remarkable each and every year. In fact, many health issues that years ago had no drugs available to help now have many that can provide relief to patients. But as you know, it is critical that professionals within the pharmaceutical industry ensure all drugs available to consumers be safe in every way possible. If you wonder how this is achieved, here are some of the most important steps in the process.
Commonly known as animal testing, this is where the path of developing any new prescription drug begins. Used to evaluate the severity of side effects and other related issues, you may be surprised to learn that the vast majority of drugs that enter preclinical testing never make it past this point.
For the prescription drugs that do make it out of preclinical trials, the next step is actual clinical trials on humans. Usually conducted in three phases, many companies choose to conduct their clinical trials through a clinical research organization. Usually working with smaller to mid-sized pharmaceutical companies, using a CRO can be helpful when your company has a smaller drug development budget, yet still wants the highest quality and standards used in the testing process.
New Drug Application
Required by the FDA, the New Drug Application (NDA) is when a drug company asks the FDA to officially consider the use of a drug within the United States. When you submit an NDA, you must include all human and animal data, a comprehensive analysis of the data by your company, and information as to how your drug is manufactured. Once you have submitted your application, the FDA then has 60 days to either reject it for being incomplete or move forward with the review.
Inspection of Your Facility
Before your company can ever gain full approval to begin manufacturing any type of prescription drug, the FDA will conduct an inspection of your facilities to ensure they meet all necessary requirements. Often done as surprise inspections, FDA investigators will carefully look over all areas of your facility, so you must be well-prepared if you believe an inspection is imminent.
These steps, along with inspecting a drug’s labeling and assigning an experienced review team to examine your drug’s safety and effectiveness, will all be key parts of the process that ultimately determines if your company’s prescription drug will be deemed safe for consumer use.