• Regulatory NewsRegulatory News

    Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak

    Contract manufacturing organization PharmaTech on Monday announced a voluntary recall of all of its liquid drug formulations made at its Davie, Florida facility over a 10-month period after being linked to a multi-state Burkholderia cepacia outbreak. The recall is an expansion of an earlier recall dated 15 July 2016, in which PharmaTech said it was recalling all lots of Diocto Liquid (docusate sodium), a stool softener, distributed by Rugby Laboratories after the com...
  • Regulatory NewsRegulatory News

    Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015

    The number of medical device recalls appears to have plunged during the first quarter of 2015, a review of the US Food and Drug Administration's (FDA) data by Regulatory Focus has revealed. FDA has since last year been publishing data about its drug and device recall reports through its new open data platform, openFDA . The data make it much easier to assess trends in enforcement measures, including the number of recalls classified by FDA. A review of FDA's device r...
  • Regulatory NewsRegulatory News

    Recall or Removal? New FDA Device Guidance Clarifies Murky Definitions

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has finally put the finishing touches on a controversial guidance regarding how to distinguish the recall of a device from a market withdrawal. Background On 21 February 2013, FDA released a draft guidance document aimed in part at establishing the requirements for distinguishing between defect- or failure-based recalls and products recalled for improvements or "enhancements." ...
  • Regulatory NewsRegulatory News

    Massive Recall of Medical Devices Largest Ever Recorded by FDA

    A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA. Background: Recall Trends The devices, which were manufactured by Puerto Rico-based device manufacturer Customed, Inc, were given a Class I recall classification —FDA's most serious recall classification, given to those devices in cases where "there is a reasonable probability t...
  • 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, ...
  • As Medical Marijuana Hits Mainstream, Regulators Take Notice With Safety Recalls

    In the US, states are increasingly squaring off against federal regulators in an attempt to grant their citizens access to medical marijuana, which advocates argue can provide pain relief to patients afflicted with cancer or other painful conditions. But north of the US border, where medicinal marijuana is legal when authorized by a doctor or nurse practitioner, Canadian regulators are grappling with another marijuana issue entirely: The recall of medicinal marijuana due...
  • UDI Implementation Still on the Horizon, FDA Updates List of Devices Which Must Be Tracked

    A new guidance document released by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) updates the agency's list of devices that manufacturers are required to track by law. Background In 1997, the Food and Drug Administration and Modernization Act (FDAMA) was signed into law. Among the law's numerous requirements is one that manufacturers track specified devices at the order of FDA. The statute, codified in the Federal Food...
  • FDA Moves Ahead With Plan to Make Device Recall and Removal Reporting More Efficient

    In June 2013, the US Food and Drug Administration (FDA) indicated that it was interested in making it easier to submit so-called "806 reports"-filings made to report the removal or correction of a medical device from the market for reasons related to human safety. Now the agency is moving forward with that proposal, submitting it this week for final government review. Background Under  21 CFR 806.10 , companies are required to make written "reports of corrections...
  • Brazil Launches New Adverse Event Reporting System

    Brazilian officials are launching an online system for health professionals to report serious or fatal accidents involving defective products or services, including healthcare products.  Health professionals will log adverse events involving drugs, devices, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC) database, initially on a voluntary basis. Reporting will eventually be mandatory. Top of Form The Municipal Hospital of Cuiab&aacu...
  • FDA Unveils Strengthened Medical Device Reporting Database With New Features

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has unveiled new improvements to its medical device recalls database, allowing members of industry and the public to more easily associate devices and safety recall issues. Prior to the new database, searches for a device yielded separate results for its labeling/approval information and any recalls. This could be problematic for healthcare providers, who would have no way of kn...
  • USPlabs Succumbs to Regulatory Pressure, Recalls Supplement Linked to Hepatitis Outbreak

    Dietary supplement manufacturer USPlabs has announced the recall of one of its workout supplements, succumbing to vigorous pressure from regulators who said the company's products had been associated an outbreak of non-viral hepatitis. Background In early October 2013, US Food and Drug Administration (FDA) issued a statement saying that it was coordinating with the Centers for Disease Control and Prevention (CDC) to investigate 29 cases of acute non-viral hepatitis as...
  • 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...