When designing a new product, it is important to consider the difference between a generic, and a clinical-grade product. Generic drugs are designed to treat a symptom, which many times is not the same as a disease. These drugs are also generally less expensive than their counterparts, which leads to them being the preferred route for many small to mid-size medical device manufacturers. The downside to these generic drugs is that they can often contain the same active ingredients as the commercial drugs that they are intended to replace. Many of the side effects that come with generic drugs can be worse than the symptoms they are supposed to mask, and therefore the FDA requires that all clinical-grade products contain a standardized form of therapeutic ingredient, that is approved for use in human beings.
A clinical-grade product manufacturer will pay close attention to the exact formulation used in the production of every pharmaceutical product that it develops. The development team will carefully monitor any changes that might be made during the manufacturing process and adjust the formulation as needed. For example, if an effective preservative is discovered during the development process that was previously not found, the development team will change the formula in accordance with its usefulness to ensure the product meets the FDA’s approval. The same holds true for any laboratory studies conducted on the newly created product.
Clinical-grade products should be free of known or documented side effects that directly relate to their use. A company must also conduct the necessary tests to ensure that the new product will not produce any harm to human health before being submitted to the FDA for approval. It is not uncommon for clinical-grade product developers to conduct a series of tests to find out if the new chemical is capable of producing any adverse results in human embryonic stem cells. Once the company is sure that the product is safe to be distributed to humans, they will then submit the new chemical for human stem cell production.