"The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:"
https://www.fda.gov/drugs/types-applications/new-drug-application-nda
"If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph (g) of this section, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.93
"In order to effectively regulate products that diagnose, treat or prevent infectious diseases, scientists and reviewers in the Center for Drug Evaluation and Research must understand the bacteria, viruses, and parasites that cause diseases. Scientists in CDER conduct many programs to advance regulatory science and research on pathogens -- agents that cause infection or disease. There are many pathogens being studied at CDER’s Office of Biotechnology Products – from food and blood-borne bacteria, to infections caused by parasites, and viruses such as the Zika virus. CDER is charged with advancing public health through the review, regulation, and research of potential treatments"
https://www.fda.gov/drugs/news-events-human-drugs/studying-how-pathogens-cause-disease
"The FDA regulates medical devices sold in the United States to assure their safety and effectiveness.
Medical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems."
https://www.fda.gov/medical-devices/products-and-medical-procedures
"the immune system responds is a relatively small number of amino acids or peptide.
A possible alternative approach to immunization would therefore be to identify the peptide sequences that trigger a protective immune response and to use completely synthetic versions of these as the vaccine substance"
https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/synthetic-peptide-vaccines
"Naessens observed that the somatid goes through a 3-stage pleomorphic cycle necessary for its reproduction, and if the immune system of the host organism (animal, human, plant) is weakened or destabilized, it grows through an additional pleomorphic 13-stage pathological cycle.
By studying the cycle, as seen in the blood of human beings suffering from various degenerative diseases such as rheumatoid arthritis, multiple sclerosis, lupus, cancer, and most recently, AIDS, Naessens has been able to associate the development of the forms of the pathological cycle with all of these diseases. Moreover, he has been able to predict the eventual onset of such diseases long before any clinical signs of them appear. In other words, he can “prediagnose” them."
https://pieceofmindful.com/2020/12/18/somatids-somadats/