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Development & Approval Process (Drugs)
How Drugs are Developed and Approved
Types of Applications
Therapeutic Biologic Applications (BLA)
Overview
Biosimilars
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Letters to Industry, Healthcare Providers, and Clinical Investigators
Therapeutic Biological Products
Letter to Abbott Laboratories Concerning Serious Manufacturing Deficiencies with Abbokinase -
7/14/1999
(pdf)
Update on Abbokinase (Urokinase)
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3/22/1999
Update on Abbokinase (Urokinase)
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3/16/1999
- Updated information is provided in the March 22, 1999 Update on Abbokinase Information Sheet
Dear Healthcare Provider: Important Drug Warning: Safety information regarding the use of Abbokinase (Urokinase)
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1/25/1999
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(PDF)
- Updated information is provided in the March 16, 1999 Update on Abbokinase Information Sheet
Difficulties in Obtaining Sufficient Amounts of Urokinase (Abbokinase)
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12/11/1998
- Updated information is provided in the January 25, 1999 Dear Healthcare Provider letter
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