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Gmp-inspection-preparation-checklist-130x160

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Oct 17

Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus

Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Editor's Picks

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FDA Warns Becton Dickinson for Potentially Contaminated Water, Environmental Conditions

The company promised to discontinue use of tap water.
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FDA Releases 25 Product-Specific Guidances for Generics

“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” said FDA Commissioner Scott Gottlieb.
FDAnews Drug Daily Bulletin

ALERT ISSUED FOR OSP PRODUCTS

May 17, 2006
KEYWORDS FDAnews Drug Daily Bulletin
A A

The FDA has notified health professions of a serious adverse event associated with oral sodium phosphates (OSP) used for bowel cleansing.

The alert cites 22 cases of acute phosphate nephropathy, a rare type of acute renal failure, in patients taking both OSP solution, such as Fleet Phospho-soda or Fleet ACCU-PREP, and tablets, such as Visicol). The FDA advises that the product should not be used in patients with such conditions as kidney disease, advanced age or decreased intravascular volume. Patients taking medications affecting renal functions should also be considered at risk.

No cases of acute phosphate nephrology have been reported in use of OsmpPrep, a recently approved OSP tablet. The full text of the alert can be viewed here (http://www.fda.gov/cder/drug/infopage/OSP_solution/default.htm).