FDA jeopardizes the lives of lung transplant recipients and in the process severely increases the cost to develop new immunosuppression

Author:

Klintmalm Goran B.1,Kaplan Bruce2,Kirk Allan D.3

Affiliation:

1. Baylor Annette C. and Harold C. Simmons Transplant Institute Dallas Texas

2. Transplant ServicesBaylor Scott & White Health Temple Texas

3. Department of SurgeryDuke University Durham North Carolina

Publisher

Wiley

Subject

Pharmacology (medical),Transplantation,Immunology and Allergy

Reference3 articles.

1. Prescription drug benefits.Social Security Act Sec. 1860D‐2 (e)(4).https://www.ssa.gov/OP_Home/ssact/title18/1860D-02.htm. Accessed December 28 2018.

2. Payment for covered outpatient drugs.Social Security Act section 1927(k)(6).https://www.ssa.gov/OP_Home/ssact/title19/1927.htm. Accessed December 28 2018.

3. Steroid-Responsive Acute Rejection Should Not Be the End Point for Immunosuppressive Trials

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4. Clarifications regarding the authority and role of FDA in drug approval;American Journal of Transplantation;2020-01-07

5. Drug Policy in the Real World;American Journal of Transplantation;2019-10-28

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