Regulatory Affairs

Medical Food
Under the prescription medical food program, a product for HDL-C and cholesterol efflux management is developed. A medical food provides nutritional support for the treatment of nutrient deficiency caused by disease and is intended to be used under medical supervision. The Medical Food market is regulated by the Orphan Drug Act and the FDA requires a recognized scientific review and Gras (generally recognized as safe) notification to approve commercialization of a medical food.

Over-the-Counter
Over-the-counter (OTC) products allow the patient to obtain such drugs without a prescription for self medication purposes. Common OTC drugs are pain relievers such as Aspirin and Advil, cold and cough medications, antihistamines, laxatives, antacids and anti-inflammatory agents. The final product can be a stand alone product (monotherapy), a co-packaged product or a blended product (combination therapy). The OTC market is regulated by the Federal Food, Drug, and Cosmetic Act (FDCA) and the FDA requires an original or amended monograph for commercialization.

Prescription drugs
Clinical and preclinical research is undergoing with the goal to develop a prescription drug targeting the increase of HDL ("good cholesterol") now recognized as a major risk factor in the development of cardiovascular disease. The prescription drug may be used as a monotherapy or in combination therapy with statins and other agents. The worldwide annual statin market is estimated at US$30 billion.

The prescription pharmaceutical market is regulated by the Federal Food, Drug, and Cosmetic Act (FDA) in the United States and a sponsor requires an investigational new drug application (IND) to run human clinical trials and a new drug application (NDA) to market a new prescription drug. In Europe, the pharmaceutical market is regulated by the European Medicines Agency (EMEA), a decentralised body of the European Union, and responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products.