Ben Venue’s Bedford Plant Resumes Producing Some Generic Injectables
Ben Venue’s Bedford, Ohio, plant — in the news this past year for quality problems — has restarted a handful of production lines to make some of its critical-need drugs available again. Injectable generics such as radiotherapy drug amifostine, muscle relaxant vecuronium, chemotherapy drug gemcitabine and vasodilator phentolamine are once more returning to market shelves. Generic Line
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The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!