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  • Regulatory NewsRegulatory News

    FDA Explains Levels of Impurity Found in Recalled Heartburn Drugs

    Following a series of recalls for the heartburn drug Zantac and other ranitidine drugs due to a genotoxic impurity, the US Food and Drug Administration (FDA) said Friday that the levels of the impurity in ranitidine drugs for heartburn and also in the chemically similar ulcer drug nizatidine “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” The agency also published a table of the ranitidine and nizatidin...
  • Regulatory NewsRegulatory News

    Study Raises Questions Over FDA’s Handling of Adulterated Supplements

    A new study published in JAMA Network Open on Friday raises questions about the US Food and Drug Administration’s (FDA) oversight of adulterated dietary supplements.   The study, which analyzed data from FDA’s Tainted Products Marketed as Dietary Supplements database, found more than 776 instances of supplements containing hidden pharmaceutical ingredients from 2007-2016.   However, only 360 of the 776 adulterated supplements were subject to a voluntary recall, w...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Provides Guidance as Black Triangle Adverse Event Scheme Goes Live Australia’s Therapeutic Goods Administration (TGA) has posted guidance on its black triangle adverse event reporting scheme. The scheme came into force at the start of the year, leading TGA to share a guide that addresses some of the uncertainties expressed by industry in advance of the go-live day...
  • Regulatory NewsRegulatory News

    Device Recalls in 2017: Making Sense of the Numbers

    Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death. But it can be difficult to quantify the number of device recalls in a year, given the multiple data sources from FDA, including a listing of annual Class I and other significant recalls , a device recalls database and a data dashboard . B...
  • Regulatory NewsRegulatory News

    House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal

    Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products. The Recall Unsafe Drugs Act would give FDA mandatory recall authority over drugs and homeopathic products. The agency confirmed to Focus that it does not have that authority. The loophole is problematic in that some compani...
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    CDRH Speeds Release of Device Recall Information

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before. The information is now posted in CDRH’s Medical Device Recalls Database at the time a firm takes a correction (which addresses a problem with a device in the place where it is used or sold) or removal action (ie., Removing the device from the market...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Starts Review of Drug Recall Guidelines The Drugs Consultative Committee (DCC) of India has committed to reviewing the guidelines on drug recalls to ensure substandard products are effectively removed from the market. Officials want to make manufacturers monitor the quality of drugs in the supply chain and hold them responsible for voluntarily recalling products that ...
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    Health Canada Issues New Medical Device Recall Guide

    Health Canada on Thursday issued a new guide on medical device recalls detailing sponsors' responsibilities under the country's Medical Devices Regulations (MDR) , replacing the agency's 2011 guidance . Specifically, the guide provides advice on keeping medical device distribution records, recalling devices, reporting recalls to Health Canada and writing internal procedures related to recalls. The guide has also been rewritten to include callout boxes and additional l...
  • Regulatory NewsRegulatory News

    Adverse Events Push FDA to Recall Portable Oxygen Systems

    The US Food and Drug Administration (FDA) on Tuesday announced that it’s calling on consumers, businesses, schools and health providers to immediately stop using OxySure Therapeutics’ Portable Emergency Oxygen System, Model 615, after the company’s voluntary recall from last year was ineffective. FDA said it has received multiple complaints and reports of adverse events associated with the device’s malfunctions, including insufficient oxygen flow, re-breathing of exhale...
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    Bacterial Infections Push FDA to Recall Certain Endoscope Washers

    The US Food and Drug Administration (FDA) on Friday again ordered a recall of all Custom Ultrasonics’ Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs), to mitigate the risk of patient infection. FDA said its most recent inspection of the Custom Ultrasonics’ facility in April documented continued violations and that the company’s AERs “have been used in health care facilities that reported the transmission of serious bacterial in...
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    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

    Up in Smoke: Canadian Regulators Find Pot too Potent

    A licensed medical marijuana producer in Canada has issued a recall for its pot-based product, saying some batches of it are too strong. According to an information update on the Health Canada website, third party tests of samples of its "Nice N'EZ" product were found to exceed the product’s labeled strength for delta-9-tetahydrocannabinol, marijuana's active ingredient. Background Medical marijuana ( spelled ‘marihuana’ in some official documents) has been regulat...