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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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Industry Worried FDA Guidance on Counterfeits Could Lead to False AlarmsIndustry Worried FDA Guidance on Counterfeits Could Lead to False Alarms

Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. . . .
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Barrage of FDA  Warnings Jolt Compounding Pharmacy IndustryBarrage of FDA Warnings Jolt Compounding Pharmacy Industry

A deluge of warning letters to compounding pharmacies appears to have jolted the industry into taking FDA enforcement more seriously, quality experts say. . . .
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Baxter Recalls More Products Due to Particulates
Who is involved: Injectable drug maker Baxter Healthcare. What happened: Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. . . . keep reading
Senator Urges Faster FDA Action on Drug Shortages
A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. . . . keep reading
Cubist Recalls Another Nine Lots of Cubicin
Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. . . . keep reading
FDA Slaps Second Impax Plant with a Form 483
Who is involved: Brand and generics maker Impax. What happened: Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts about the company’s plan to win approval of its Parkinson’s drug Rytary. . . . keep reading
FDA Warns Compounding Pharmacy for Lax Aseptic Processing
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs. . . . keep reading
Cubist Conducts Massive Recall Due to Glass Particles
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials. . . . keep reading
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