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Article: FDA mandates approval for all pancreatic enzyme replacement products.
- Article from:
- Drug Week
- Article date:
- May 28, 2004
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2004 MAY 28 - (NewsRx.com & NewsRx.net) -- The Cystic Fibrosis Foundation announced its support of the U.S. Food and Drug Administration's (FDA) requirement that manufacturers of pancreatic enzyme replacements obtain FDA approval for their products within the next 4 years.
This rule allows enzyme products to remain available to patients during that time. At the CF Foundation's urging, an FDA review found that inconsistencies in the formulation, dosage and manufacturing processes of many enzymes could significantly compromise both the safety and effectiveness of the drugs in patients with pancreatic diseases, including cystic fibrosis (CF).
The CF ...