drug development & discovery by fda standards

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Drug Development & Discovery by FDA Standa rds What Happens During Each Stage of The Drug Discovery and Approval Process? Find Out from the Expert! Presenter - Angela Bazigos Follow us :

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Post on 18-Jan-2016

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Expert speaker Angela Bazigos would lay out the whole process systematically and in a simplified manner.

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Page 2: Drug Development & Discovery by FDA Standards

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Contents

Why the “FDA Way” High Level Process The FDA’s view The Code of Federal Regulations (CFR) Summary Q & A

Page 3: Drug Development & Discovery by FDA Standards

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Why the FDA Way

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4The Tuskegee Syphillis Study The Tuskegee syphilis experiment was an infamous clinical study

conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government. [1]

The Public Health Service started working with the Tuskegee Institute in 1932. Investigators enrolled in the study a total of 600 impoverished sharecroppers from Macon County, Alabama. 399 of those men had previously contracted syphilis before the study began, and 201[2] did not have the disease. The men were given free medical care, meals, and free burial insurance, for participating in the study. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood", a local term for various illnesses that include syphilis, anemia, and fatigue.

The 40-year study was controversial for reasons related to ethical standards, primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying. Revelation of study failures by a whistleblower led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require informed consent (though foreign consent procedures can be substituted which offer similar protections; such substitutions must be submitted to the Federal Register unless statute or Executive Order require otherwise),[3] communication of diagnosis, and accurate reporting of test results.[4]