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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.

Events

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Oct 16

Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities

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

Editor's Picks

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Health Canada Gives Green Light to Medtronic’s Insulin Pump

The company expects to launch the insulin pump in Canada this fall.
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Lawsuit Accuses Westminster, CVS of Selling Recalled Thyroid Tablets

The complaint alleges that Westminster knew there were problems with the drugs for months but didn’t recall them until after the FDA forced its hand.

FDA APPROVES CUBICIN FOR MORE USES

KEYWORDS Drug Pipeline Alert
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The FDA has approved a much broader use for Cubist Pharmaceuticals's Cubicin intravenous antibiotic.

The approval involves expanding Cubicin's indication from skin infections to also treat bloodstream infections, including a form of endocarditis. Cubist said it will begin marketing immediately.