01 Investigational therapy statement
21 CFR 312.6 · 21 CFR 312.7 · FD&C Act Section 505
Therapies referenced or linked from FixCancers.com that have not received marketing authorization from the United States Food and Drug Administration are investigational. An investigational drug or biologic is one in clinical development under an Investigational New Drug application (IND) or comparable framework. Investigational status means the agency has not concluded that the product is safe and effective for any indication.
FixCancers.com does not assert that any investigational therapy referenced on this site is safe or effective for any specific purpose. Eligibility for any investigational therapy is determined by the responsible clinical investigator under the applicable protocol.
02 21 CFR 312.7 promotion limits
21 CFR 312.7 · FTC Act Section 5
FDA regulations prohibit sponsors and investigators from representing in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation, or from otherwise promoting the product before approval. FixCancers.com complies with 21 CFR 312.7 by:
- Limiting all references to investigational therapies to factual, scientific information.
- Avoiding comparative claims, efficacy claims, and safety claims for unapproved products.
- Not charging for investigational therapies beyond the cost recovery permitted under 21 CFR 312.8 where applicable.
- Not using patient testimonials, before-and-after imagery, or success-rate statistics for unapproved therapies.
Content on this site is informational. Nothing on FixCancers.com should be interpreted as the offer or sale of an unapproved medical product.
03 No medical advice
Common law · State medical practice acts
Content on FixCancers.com is for general informational and educational purposes. It is not medical, diagnostic, therapeutic, or clinical advice. The information presented here is not a substitute for consultation with a licensed treating physician, oncologist, or other qualified healthcare professional.
Patients should make treatment decisions in consultation with their treating clinical team. Patients should not start, stop, or modify any treatment based on information obtained from this site.
04 No doctor-patient relationship
State medical practice acts · Federation of State Medical Boards model
Use of FixCancers.com, submission of an intake request, communication with the intake team, and access to any content on this site do not create a physician-patient, clinician-patient, or therapeutic relationship between any visitor and any clinician, clinic, or sponsor referenced on this site.
A clinical relationship is established only after a licensed clinician at a partner clinic completes formal intake, eligibility review, and provider-patient agreement under the applicable jurisdictional standard of care.
05 No outcome guarantees
FTC Act Section 5 · Lanham Act Section 43(a)
Cancer is a complex disease. Individual patient response to any therapy, approved or investigational, varies based on tumor biology, stage, prior treatment, comorbidities, and other factors. FixCancers.com makes no representation, warranty, or guarantee of any clinical outcome, including but not limited to tumor response, survival benefit, quality-of-life improvement, or absence of adverse events.
No individual outcome described or referenced on this site is typical, predictive, or guaranteed.
06 United States access pathways
21 CFR 312 Subpart I · FD&C Act Section 561 · Right to Try Act of 2018 (Pub. L. 115-176)
Access to investigational therapies in the United States is governed by federal regulation. The pathways referenced from FixCancers.com are:
Clinical trial enrollment
Most patients access investigational therapy through registered clinical trials. Trials are listed on ClinicalTrials.gov and other registries. Eligibility is determined by the trial protocol, investigator review, and informed consent under 21 CFR 50.
Expanded Access (21 CFR 312 Subpart I)
Expanded Access, also called compassionate use, permits the use of an investigational drug outside a clinical trial for patients with serious or life-threatening conditions who lack comparable alternatives. The pathway requires sponsor agreement, FDA authorization, IRB review, and informed consent. Detailed criteria appear at FDA Expanded Access.
Right to Try Act of 2018
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (Pub. L. 115-176) permits eligible patients with life-threatening conditions to access certain investigational therapies that have completed Phase 1 clinical trials and remain in active development. Eligibility, sponsor participation, and clinical determinations are made by the treating physician and the sponsor. The Right to Try pathway does not require FDA authorization for individual access.
07 Mexico regulatory pathway
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Mexican partner clinics referenced on FixCancers.com operate under the regulatory authority of the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the national health-products regulator. Treatment in Mexico is subject to Mexican law, COFEPRIS clinical requirements, and the standard of care of the treating clinic.
United States residents who travel to Mexico for clinical care do so outside the regulatory authority of the FDA. FixCancers.com does not solicit United States patients to receive unapproved therapies in foreign jurisdictions. The decision to seek treatment outside the United States rests entirely with the patient and the patient's treating clinical team.
08 Australia regulatory pathway
Therapeutic Goods Administration (TGA) Special Access Scheme
Australian partner clinics referenced on FixCancers.com access investigational therapies through the Therapeutic Goods Administration Special Access Scheme (SAS). The Special Access Scheme provides authorized supply of unapproved therapeutic goods to individual patients on a case-by-case basis, subject to TGA notification or approval depending on category. Categorical criteria and current guidance appear at the TGA Special Access Scheme portal.
09 Testimonials and results
FTC Endorsement Guides 16 CFR Part 255 · 21 CFR 312.7
FixCancers.com does not publish patient testimonials, success-rate statistics, before-and-after comparisons, or anecdotal outcome reports for investigational therapies. The decision to exclude this content is intentional and reflects both 21 CFR 312.7 promotion restrictions and FTC Endorsement Guide requirements at 16 CFR Part 255.
Patients interested in clinical evidence should request the published literature, trial protocols, and investigator reports through the intake team. Source documents are provided directly rather than summarized in promotional form.
10 HIPAA and protected health information
HIPAA Privacy Rule 45 CFR 160 and 164 · HITECH Act
FixCancers.com is an independent informational resource. It is not a covered entity under the HIPAA Privacy Rule (45 CFR Parts 160 and 164). The intake form, the intake email address (intake@fixcancers.com), and the intake team are not subject to HIPAA's covered-entity obligations.
What this means for patients
Information voluntarily submitted to FixCancers.com through the intake form or email is treated as confidential within the FixCancers.com network but is not subject to HIPAA's covered-entity protections. Once a patient enters a clinical relationship with a partner clinic or treating physician, that clinician operates under the privacy framework applicable to their jurisdiction.
What patients should not send before clinical engagement
- Full medical record copies
- Detailed imaging files
- Pathology slides
- Insurance information
The intake team requests these materials only after eligibility review and only through a secure channel established by the clinical team.
11 Privacy notice and form data
CCPA · CPRA · State privacy frameworks
Information submitted through the intake form is collected, processed, and stored for the purpose of clinical eligibility review. The site processor for form submissions is FormSubmit.co. Form data is routed to intake@fixcancers.com and forwarded to the FixCancers.com clinical review address.
Data collected
- Patient or contact name
- Email address
- Phone number (optional)
- Country of residence
- Primary tumor type
- Current stage
- Treatment history (narrative)
How data is used
- Routing to the clinical review team
- Eligibility determination
- Follow-up communication regarding the intake request
Data retention
Intake submissions are retained for the duration of the clinical engagement and for the period required by the responsible jurisdiction. Patients may request deletion of their intake record at any time by emailing intake@fixcancers.com with the subject line "Data deletion request."
No third-party tracking
FixCancers.com does not run third-party advertising trackers, behavioral analytics pixels, or cross-site cookies. The site does not sell or share patient information for marketing or commercial purposes.
12 International privacy
EU General Data Protection Regulation (Regulation 2016/679) · UK GDPR · Australia Privacy Act 1988
Visitors from the European Union, the United Kingdom, and Australia have additional privacy rights under regional law. These include the right to access, correct, port, or delete personal information held by FixCancers.com. To exercise these rights, email intake@fixcancers.com with a description of the request.
FixCancers.com does not run cookies, tracking pixels, or behavioral analytics that would trigger GDPR consent requirements. The Sienna accessibility widget loaded on this site runs client-side, sets no cookies, and transmits no personal data.
13 Independent resource status
FixCancers.com operates as an independent patient resource. The site is not a clinical trial sponsor, a manufacturer, a distributor, or a covered entity. The intake team facilitates eligibility review and connects qualified patients with partner clinics, treating physicians, and clinical investigators.
Content on this site reflects publicly available scientific information, published regulatory pathways, and the operational reality of the partner clinic network. It does not reflect the views of any individual manufacturer, sponsor, or institution.
14 Relationship to FixCancer.org
FixCancers.com (plural) and FixCancer.org (singular) are coordinated patient-facing resources. FixCancer.org documents a specific clinical-stage targeted therapy in technical detail. FixCancers.com provides broader patient education, intake, and access-pathway content.
Cross-references between the two sites are factual. The relationship between FixCancers.com and FixCancer.org is editorial coordination, not commercial promotion.
15 Financial relationships
Anti-Kickback Statute 42 U.S.C. § 1320a-7b · Stark Law 42 U.S.C. § 1395nn · State self-referral laws
Operations of FixCancers.com and the partner clinic network are structured to comply with applicable federal and state laws governing patient referrals, financial relationships among healthcare providers, and prohibition on payment for patient referrals.
No payment, fee, kickback, or other inducement is paid or received by FixCancers.com in exchange for patient referrals to any partner clinic, treating physician, or investigational therapy program. Patients are not charged a fee to be evaluated for eligibility.
Where investigational therapy involves cost recovery permitted under 21 CFR 312.8, the cost-recovery structure is disclosed to the patient in writing before treatment begins.
16 Advertising and promotion compliance
21 CFR 312.7 · FDA Bad Ad Program · FTC Act Section 5
FixCancers.com does not run paid advertising for investigational therapies. The site does not use search-engine marketing, social-media advertising, sponsored content, or paid endorsements to promote unapproved products.
All inbound traffic to FixCancers.com comes from organic search, direct visits, and patient referral. The site complies with the FDA Bad Ad Program standard for honest, balanced presentation of medical information.
17 Patients under 18
21 CFR 50 Subpart D · 45 CFR 46 Subpart D · COPPA
The intake process for patients under 18 years of age requires parental or legal-guardian consent, and where applicable, pediatric assent under 21 CFR 50 Subpart D. The intake team requests guardian information at the screening conversation and routes pediatric cases to clinical teams qualified to evaluate pediatric eligibility.
FixCancers.com does not knowingly collect personal information from children under 13 in violation of the Children's Online Privacy Protection Act (COPPA).
17b Partner clinic operational permits
Mexican partner clinics referenced from FixCancers.com hold current operational permits from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). Australian partner clinics operate under licenses from the Therapeutic Goods Administration (TGA) and applicable state health authorities. United States partner sites operate under federal IND authorization, IRB approval, and state medical licensure of the treating clinicians. Permit documentation is provided to patients during the eligibility review.
17c Risks of travel for medical care
Travel for medical care carries logistical, clinical, and financial risks distinct from receiving care in the patient's home jurisdiction. Patients should discuss the following with their treating clinical team before traveling.
- Pre-travel medical clearance for performance status and comorbidities
- In-flight management of indwelling lines, ports, ostomies, or active wound care
- Continuity of standing oncology medications and supportive therapies
- Emergency-care standards in the destination jurisdiction
- Language access and interpreter availability
- Post-treatment follow-up and complication management on return home
- Medical travel insurance for repatriation, hospitalization, and trip interruption
The intake team coordinates pre-travel checklists with the partner clinic before scheduling.
17d Payment coordination
Where FixCancers.com facilitates payment, it does so as a coordination service between patient and partner clinic. FixCancers.com is not a clinical provider, not a third-party payor, and not an escrow service. Payment terms, refund policies, and clinical service obligations are agreed directly between the patient and the treating partner clinic in a written engagement letter.
International payments are subject to currency conversion, wire-transfer fees, and applicable cross-border reporting. Patients should verify whether their bank, employer plan, or insurer imposes restrictions before initiating payment.
17e Not an insurance provider
FixCancers.com is not an insurance company, not a third-party administrator, and not a benefits manager. The site does not issue, underwrite, broker, sell, or process insurance products. The site does not guarantee insurance coverage, reimbursement, or pre-authorization for any therapy referenced or linked.
Patients should verify insurance coverage with their carrier directly before initiating travel or treatment. Where applicable, the partner clinic provides documentation suitable for post-treatment reimbursement claims.
18 Medical emergencies
FixCancers.com is not an emergency resource. Patients experiencing a medical emergency should call 911 in the United States, 060 in Mexico, 000 in Australia, or the equivalent emergency line in their jurisdiction. Patients experiencing acute clinical deterioration should contact their treating physician or the nearest emergency department immediately.
19 Updates to these disclosures
These disclosures are reviewed quarterly and updated when regulation, partner clinic operations, or site functionality changes. The "Last updated" date at the top of this page reflects the most recent revision. Patients should review these disclosures before each intake submission.
20 Regulatory contact
Regulatory questions, data requests, and disclosure concerns are routed through the intake address.
Email intake@fixcancers.com with subject line "Regulatory inquiry."