The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices

    The US Food and Drug Administration (FDA) has reiterated its recall of Custom Ultrasonics' automated endoscope reprocessors (AERs) after the company had proposed to correct, rather than recall the AERs, which FDA rejected as the devices fail to adequately wash and disinfect endoscopes. Duodenoscopes Duodenoscopes are a type of endoscope manufactured and sold in the US by Fujifilm, Pentax and Olympus and are notoriously difficult to clean. Customs Ultrasonics AERs, whic...
  • Regulatory NewsRegulatory News

    EU Committee Takes on Adverse Event Reporting for Veterinary Drugs

    Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting. Background EMA, along with national regulators, is tasked with monitoring and collecting post-market surveillance data on veterinary medicines. This is done prima...
  • Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data

    A new report published by the US government Accountability Office (GAO), a intra-government watchdog that assesses programmatic weaknesses, has informed the US Food and Drug Administration (FDA) that it could be doing a better job at utilizing the information it collects on adverse events for dietary supplement products. Background The 18 March 2013 report reflects a complicated regulatory area for the agency, in which products-some of which contain pharmaceutical or ph...
  • Canada's 2011 Adverse Event Data Shows Increasing Number of Reports

    Canadian health regulators have released a detailed breakdown of all adverse event reports submitted to Health Canada in 2011, providing a number of interesting insights and trends. Health Canada said it had received 41,923 domestic adverse event reports (AERs), of which 78% were classified as "serious" adverse events. The overwhelming majority of these cases concerned pharmaceutical products (27,602) and biotechnology products (12,419). The remaining products-blood prod...
  • Post-FDAAA, Regulators Move to Adapt to Changing Risk Models

    With all the attention given to the US Food and Drug Administration's (FDA) approval process, it can sometimes be easy to forget an equal amount of its time is spent on postmarketing issues related, in part, to product safety. Two components of assuring a product's safety involve adverse event reporting (AER) and risk management plans, both of which were the focus of a presentation given at Harvard Medical School in early May 2012. In his presentation, Dr. Gerald Dal Pan...
  • Sixteen Drugs Identified by AERS as Potentially Having Serious Risks

    Sixteen drugs were identified by the Adverse Event Reporting System (AERS) during the fourth quarter of 2011 and have been flagged by the US Food and Drug Administration (FDA) for further review, the agency said in a statement on its website. The products, which include Fluoroquinolone-based products, Imodium, proton pump inhibitors and Vertex's hepatitis C drug Incivik, were determined to have potential safety issues in FDA's 17 April posting. FDA noted no causal relat...
  • Australian Adverse Event Database Hits Milestone

    Australia's Therapeutic Goods Administration (TGA) announced its adverse reactions database hit a milestone 4 April, logging a quarter of a million valid reports. The database, which has been running since 1971, is used by TGA to determine is regulatory action is necessary to protect the public from an already-approved product. "The TGA would like to thank all report contributors," the agency said in a statement. "Such information is vital to TGA efforts to promote the ...
  • Australia Launches Simplified Medical Device Adverse Event Reporting System

    Australia's Therapeutic Goods Administration (TGA) released a new online system for reporting adverse events (AEs) attributable to medical devices this week. In a 14 March press release, TGA noted that the system "consists of forms with easy-to-follow instructions for users and sponsors and manufacturers." Once the medical device AE report has been submitted, "any follow-up or final reports will still have to be submitted by email, fax or mail" until TGA is able to lau...