Early Patient Access to Investigational 博彩app软件下载

At 博彩app软件下载 Myers Squibb, patients are at the center of everything we do. Every day, we come to work committed to our mission -- to discover, develop, and deliver transformational medicines that help patients fight serious disease.

Our employees are motivated by this single focus and work tirelessly with the hope that our scientific insights can be translated into new medicines that make a meaningful difference in the lives of patients. We work with urgency, knowing that many patients 博彩app软件 the world are waiting for new therapeutic options.

We receive many inquiries 博彩app软件 our investigational medicines, including requests outside of our clinical trials – a practice commonly referred to as “compassionate use” (which we call “early patient access”). This is an important topic for our company, as we know that many of the patients seeking access to our investigational medicines are facing a serious or life-threatening illness and often have no further treatment options or a clinical trial available to them. We welcome requests for early patient access from the physicians treating these patients and we take great care to have each individual patient case assessed by a physician on our staff. Our goal with our early patient access programs is to ensure that appropriate patients can obtain access to our investigational medicines.

Decisions 博彩app软件 early patient access to our investigational medicines are made after considerable thought. Our first concern is that of any doctor, namely the safety and well-being of the patient. This is especially important because these medicines have not completed the normal course of studies for the indications at issue. Then, consideration must be paid to the possibility of a benefit for the patient based on what we know 博彩app软件 the investigational medicine at the time. In this regard, we work closely with the patient’s physician to determine whether access to the investigational medicine is best for the patient. We also make sure that medicines are provided in a fair and equitable manner, but there is no guarantee that every request will be fulfilled.

Lastly, we must ensure that, by providing an investigational medicine to an individual outside of a clinical trial, it in no way compromises the scientific validity of the broader development program or delay any regulatory filings, which are aimed at making the medicine available to help many more patients through regulatory review and approval.

If you are a patient with questions concerning access to an investigational medicine -- either through a clinical trial or under compassionate use – please discuss your situation with your treating physician.

Early patient access requests must be made through your physician who can reach 博彩app软件下载 Myers Squibb by visiting 博彩app软件下载 Myers Squibb Early Patient Access Requests. 博彩app软件下载 Myers Squibb strives to respond to the request as quickly as possible, usually within 48 hours. You can also access more information on our clinical trial programs at 博彩app软件下载 Myers Squibb Study Connect

Please note: as of 2019, 博彩app软件下载 Myers Squibb and Celgene have merged. For further information regarding pre-approval access to legacy Celgene investigational products, refer to the information below. 

We encourage patients to speak with their physicians 博彩app软件 eligibility to enroll in any of Celgene’s clinical trials. Learn more 博彩app软件 Celgene clinical trial programs.

Qualified physicians may request information on Celgene’s Pre-Approval Access Programs (e.g., Expanded Access Programs, including the single-patient “Named Patient Program” and/or emergency requests) by contacting Celgene’s Medical Information Department at 1-888-771-0141 or 1-908-673-9800 or by completing this online request form.   

We strive to respond to expanded access requests as quickly as possible.   We cannot make a guarantee that the investigational therapy will be available to a particular patient. Any Pre-Approval Access to investigational therapies must always comply with the applicable country-specific laws and regulations, including importation requirements, approvals from applicable regulatory bodies, and by an appropriate Institutional Review Board. 

Specific eligibility criteria must be met for access outside of a clinical trial. These criteria include:

  • The illness must be serious or life threatening
  • There are no other viable options (including approved products or active clinical trials)
  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
  • There is a plan by 博彩app软件下载 Myers Squibb to make the medicine, once approved, available commercially in the country from which the request was received
  • Whether or not sufficient quantities of the investigational medicine are available
  • Additional criteria regarding the therapy, its development program, the patient, or other circumstances may impact eligibility

This is an unprecedented time for scientific innovation and the development of important new medicines. At 博彩app软件下载 Myers Squibb, we are doing everything we can to ensure that patients with serious disease get the benefit of these innovations as quickly as possible.

For further information or to request access to a 博彩app软件下载 Myers Squibb or hCelgene investigational product, please discuss with your physician.

Right to Try Act

In May 2018, the President of the United States signed into law the Right to Try Act.

博彩app软件下载 Myers Squibb supports efforts to improve the safe and timely access to investigational medicines for patients facing a serious or life-threating illness and who have no further treatment options or a clinical trial available to them. We believe our current approach to early patient access, as outlined above, is consistent with the objectives of the Right to Try Act. Requests for early patient access to 博彩app软件下载-Myers Squibb investigational medicines should continue to be made through the treating physician and by visiting 博彩app软件下载 Myers Squibb Early Patient Access Requests Portal


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