Important, please read. This is a business-to-business program for licensed healthcare providers and approved clinics only. Newera does not market to, sell to, or ship to patients, and verification is required before any ordering access is granted.
Product descriptions on this page are educational summaries for licensed providers. They are not treatment claims, not medical advice, and not a representation that any product is FDA-approved to diagnose, treat, cure, or prevent any disease. Compounded preparations are not FDA-approved products. Some compounds referenced here are investigational or are subject to evolving FDA guidance on compounding, and availability may change accordingly.
Biologics notice. Products described as exosomes, extracellular vesicles, or perinatal-tissue-derived preparations are biological products. They are not FDA-approved biologics, and no representation is made that any such product is licensed under Section 351 of the Public Health Service Act. Regulatory classification (including 361 vs. 351 status and any investigational-new-drug requirements for non-homologous use) is the responsibility of the ordering provider and the fulfillment partner. Availability is subject to current FDA guidance on cell, tissue, and exosome products, which continues to evolve.
Providers are responsible for patient selection, informed consent, prescribing within their license and state scope, and compliance with all applicable state and federal law. Products and protocols are made available only to eligible providers. If you are a patient, please talk to your provider.