• Regulatory NewsRegulatory News

    Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns

    Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month. Background Pharmaceutical companies occasionally need to recall—that is to say, remove—products from the market. While the reasons for product recalls vary, they are commonly related to packaging defects, ...
  • Regulatory NewsRegulatory News

    FDA Wants to Make Product Recalls Easier to Track

    A little more than a month after first launching its long-anticipated openFDA project, the US Food and Drug Administration (FDA) has announced that it hopes the project can do for product recalls what it has already done for adverse event data. Background The openFDA initiative was born from a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and...
  • Device Recalls Surge While Pharma Offers Mixed News in Latest Recall Report

    A report published this week by the recall consulting group ExpertRecall analyzing the number of recalls in the regulated healthcare product sector shows that both pharmaceutical and medical device recalls continued to fall within historical norms, even as both fluctuated-for better and for worse-from previous quarters. Background In the US, the recall of pharmaceutical and medical device products is largely conducted on a voluntary basis by companies, who often wish to...
  • Pharmaceutical, Device Recalls Spike in Second Quarter, Led by Compounding and Global Trends

    Pharmaceutical recalls, and especially serious Class I pharmaceutical recalls, are up substantially from previous quarters, according to a new report from the recall consulting firm Stericycle. The reports, which Stericycle publishes on a quarterly basis, serve as a snapshot of several industries, including the pharmaceutical and medical device industries, breaking down recalls by time, product type and recall severity. Pharmaceutical Trends Pharmaceutical recalls saw ...
  • Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles

    • 16 May 2013
    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 large-scale medical device problems. Pharmaceuticals Pharmaceuticals as a category is made up of two types of products: Drugs manufactured under traditional conditions, such as in a large-scale manufacturing facility, and drugs that are compounded, often on a one-off bas...
  • FDA Draft Guidance Aims to Clarify Difference between Recalls and Removals

    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. Background Recall regulations stipulate that any action taken by a manufacturer to correct a defect or performance failure that could pose a risk to public health may be defined as the agency as a recall, even if the action is conducted voluntarily, as it often is. In those cases, manufacturers are required by 21 CFR 806 to sub...
  • Report: Repeat Recalls by Device Companies at 30-Month High

    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 products fell slightly in the fourth quarter of 2012 relative to Q3, but the number of recalled units fell dramatically. Those recalls generally fall into one of two categories: voluntary recalls, which comprise the vast majority of all recall activity, and mandatory recalls,...
  • India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines

    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 closely into line with the recall system used by US regulators. The intent of the rapid alert system is to place special emphasis on urgent recalls with the potential to seriously affect patients or the consuming entity (in the case of veterinary products, animals). These alerts...
  • Report: Recall Trends Generally Flat Through First Half of Year

    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 Stericycle . The report, part of a long-running analysis published by the company on a quarterly basis, looks at product recalls in the US under the jurisdiction of the US Food and Drug Administration (FDA). While general trends were relatively flat, the company noted that the number o...
  • FDA Looking to Overhaul Compliance Approach

    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 biologics products, according to Mark Roh, regional food and drug director for FDA's Pacific Region. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies. The Need for Change In a presentation to th...
  • Revised FDA Enforcement Report Stresses Clarity, Data Accessibility

    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 to the reports starting today. On 21 June, FDA announced it has completed a planned revision of the reports to make information easier to understand, quicker to read and more accessible to technology. In an announcement in early June 2012 , FDA said it planned to roll out a ...
  • FDA Plans Major Overhaul of Recall Reporting

    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 announcement. The agency last week reported in a little-noticed item within its enforcement report that it would be making changes to the way it updates its enforcement reports for pharmaceutical product recalls. The agency wrote at the time it intends to "modify the drug pro...