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Theqmnweeklybulletin

April 20, 2012

Vol. 4 No. 16

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Devicemakers Say EU Approval Path Doesn’t Trump U.S. FDA Process

Taking a device to Europe to gain quicker access to market compared with the U.S. Food & Drug Administration (FDA) review mechanism is a short-term fix, not the solution to maintaining the pace of industry innovation. Read More

For Suppliers, cGMP Compliance Not Always Stated, But Expected

The quality of any material that goes into a medicinal product remains the manufacturer’s responsibility. From the perspective of the FDA and other countries’ regulators, audits are one good way to reinforce confidence in suppliers. Read More

Wheelchair Lift MakerWarned on CAPA, Complaint Handling

A bevvy of concerns about complaint handling and inventory led to an FDA warning letter for wheelchair-lift maker ThyssenKrupp Access Manufacturing. Read More

Preparing for the Future, Getting Ready for eCTD

It will likely be four to five years before drug sponsors are forced to submit their investigational, new drug and biologic license applications via the electronic common technical document (eCTD) format. Read More

Metallic Particulate Problems Spur Form 483 for Alkermes’ Ohio Plant

Employees at Alkermes’ Wilmington, Ohio, facility repeatedly found metallic particles in drug product samples during testing, but remediation efforts were thwarted by inadequate plant procedures, a Form 483 handed to the global biopharmaceutical company states. Read More

Senate Bill Would Boost Flow of Device Supply Chain Data

The FDA would be required to implement a unique device identification (UDI) system by the end of 2013 if a new Senate bill becomes law. Read More

Wheelchair Lift Firm Warned on CAPA, Complaint Handling

A bevvy of concerns about complaint handling and inventory led to an FDA warning letter for wheelchair-lift maker ThyssenKrupp Access Manufacturing. Read More

Hospira, CSL Biotherapies Recall Drugs on Manufacturing Issues

Hospira is recalling one lot of its morphine sulfate injection and CSL Biotherapies is recalling a number of batches of an albumin intravenous solution after both companies found manufacturing irregularities. Read More