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FDA Issues Guidance on CMO Quality Accords

The FDA has issued long-awaited guidance on how drugmakers and their contract manufacturing partners can best use quality agreements to ensure safe and effective drugs. The guidance recommends companies establish formal quality agreements with contract manufacturers and testing labs, and that they build strong safeguards into the agreements. The guidance will be welcome news to FDA investigators, who now routinely review quality agreements during inspections but have lacked guidance on what a good agreement should contain. The guidance, at a mere 12 pages, is unlikely to resolve all issues. But it does offer the industry the agency's perspective on a number of key issues. . . .
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Experts Urge Stronger Chinese Supply Chain Surveillance to Protect U.S. ConsumerExperts Urge Stronger Chinese Supply Chain Surveillance to Protect U.S. Consumer

Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. . . .
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GSK Alerts Public to Tampering of OTC Weight Loss DrugGSK Alerts Public to Tampering of OTC Weight Loss Drug

Pharma giant GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. . . .
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Indian Regulators Suspend Imports from Troubled Ranbaxy Plant
Who is involved: Indian drugmaker Ranbaxy. What happened: Indian authorities quietly suspended Ranbaxy's Toansa facility from exporting active pharmaceutical ingredients (APIs) to Europe late last month, signaling the country's new, tougher approach to manufacturing quality violations. . . . keep reading
Impax Refiles NDA After Manufacturing Woes
Impax said it has refiled an NDA for its Parkinson's disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. . . . keep reading
FDA Bars Imports From Another Indian Manufacturer
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. . . . keep reading
GSK Warned for GMP Shortfalls, Wholesaler Recall Proposed
Who is involved: U.K.-based pharma giant GlaxoSmithKline subsidiary Smithkline Beecham. What happened: The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant. . . . keep reading
FDA Adds Apotex to India-Based Import Ban List
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Drugs manufactured at the Apotex Pharmachem India plant will be detained without physical examination, the import alert says. . . . keep reading
West-Ward Closes Out Warning Letter After Quality Revamp
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Hikma Pharmaceuticals, which owns West-Ward, announced the closeout of the 2012 warning letter last week. The company says it spent tens of millions of dollars on remediation. . . . keep reading
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