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Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles

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Recall reporting and consulting firm Stericycle is out with its latest quarterly report regarding the state of industry recalls, showing a disturbing trend in recalls led by compounding pharmacies and Read More...

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FDA Draft Guidance Aims to Clarify Difference between Recalls and Removals

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When is a recall not really a recall? Between the US Food and Drug Administration (FDA) and industry, this has long been a point of contention.BackgroundRecall regulations stipulate that any action Read More...

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Report: Repeat Recalls by Device Companies at 30-Month High

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A new report out today from the recall company SteriCycle focusing on recalls overseen or ordered by the US Food and Drug Administration (FDA) shows that recalls of pharmaceutical and medical device Read More...

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Study: FDA Enforcement Actions against Device Manufacturers Increasing

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A study recently released by regulatory consulting group Greenleaf Health finds that enforcement actions taken by the US Food and Drug Administration (FDA)'s Center for Device and Radiological Health Read More...

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India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines

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India's Central Drugs Standard Control Organisation (CDSCO) has released a new draft guideline on a new recall and rapid alert system for chemical and biological drug products, bringing it more Read More...

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Report: Recall Trends Generally Flat Through First Half of Year

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Consumer product recalls initiated for pharmaceuticals and medical devices remained largely flat during the second quarter (Q2) of 2012, according to a new report published by recall firm Read More...

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FDA Looking to Overhaul Compliance Approach

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The US Food and Drug Administration (FDA) is headed toward a marked change in compliance policy in the coming years as the result of rapidly surging imports of pharmaceutical, medical device and Read More...

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Revised FDA Enforcement Report Stresses Clarity, Data Accessibility

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Regular readers of the US Food and Drug Administration’s (FDA) weekly enforcement reports—the vehicle through which the agency publishes recalls initiated by or reported to FDA—will see a big change Read More...

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FDA Plans Major Overhaul of Recall Reporting

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The US Food and Drug Administration’s (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency Read More...

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Study: FDA Recall Communication System Ineffective, Poorly Designed

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It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant Read More...

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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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