| Recently, I was asked to review with FDA rigor | | | | regulatory pathway with FDA rigor. |
| and "investor" interest and due diligence, several | | | | At some point in life cycle of the neutraceutical |
| NCEs (New Chemical Entities) for various | | | | and because of the "apparent" medical benefit of |
| therapeutic indications, all in areas of unmet | | | | the neutraceutical, FDA will step in and demand |
| medical needs, inhalation devices, state of the art | | | | that the formulation, the product, become |
| and several neutraceutical products. For this | | | | quality-controlled and assured and regulated. FDA |
| article, the focus is on neutraceuticals. | | | | will want the neutraceutical company to submit a |
| Neutraceutical, a term combining the words | | | | clinical and regulatory submission and product filing. |
| "nutrition" and "pharmaceutical", is a food or food | | | | It will happen - it is just a matter of time. In the |
| product that provides health and medical benefits, | | | | last two years, across my desk, four |
| including the prevention and treatment of disease. | | | | neutraceutical companies in business for at least |
| Interestingly enough, the FDA is closing in on | | | | 10+ years have been contacted by FDA to |
| neutraceuticals. These are products that are | | | | provide a clinical development and submission plan |
| generating revenue on the market, manufactured | | | | for filing. |
| by top pharma manufacturing facilities, formulated | | | | Therefore, If you are a neutraceutical company, it |
| and contain active substances which in addition to | | | | is reasonable to expect it will happen to you. If it |
| the primary product "marketed" claim - lowers | | | | does, FDA will want to see in a realistic time |
| cholesterol, while building muscle and correcting | | | | frame, your intent to comply with their request |
| hormonal balance - as well demonstrates efficacy | | | | for FDA rigor. In future articles and in blog posts |
| or benefits in other areas, for example CNS | | | | on the Dante Resources blog, I will speak about |
| (Central Nervous System) - demonstrates a | | | | how to comply and the components of the filing |
| sense of well being in patients diagnosed with | | | | in. In addition, I will provide a brief checklist on due |
| bipolar, schizoaffective, psychosis, etc. These are | | | | diligence from an investor's point of view as well. |
| products that have not traveled the clinical and | | | | Stay tuned! |