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

1. Drug Development & Discovery by FDA Standards
What Happens During Each Stage of The Drug Discovery and Approval Process? Find Out
from the Expert!
Presenter - Angela Bazigos
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2. Contents
 Why the “FDA Way”
 High Level Process
 The FDA’s view
 The Code of Federal Regulations (CFR)
 Summary
 Q & A
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3. Why the FDA Way
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4. The 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]
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5. To see the complete presentation check the below link:
http://www.audioeducator.com/pharma-biotech/review-of-fda-standards-in-
drug-development-11-2014.html