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  • Regulatory NewsRegulatory News

    FDA Makes Drug Safety Labeling Change Information Easier to Access

    The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), which has created a new database that provides data to the public in downloadable and searchable formats. “With this transition, safety labeling change (SLC) data on the Web will now be available much faster for health care providers, health information technol...
  • Regulatory NewsRegulatory News

    Tufts CSDD Raises Questions over Adverse Event Reporting in US

    Inconsistencies in the way adverse event reports are filled out and sent to the US Food and Drug Administration (FDA) could mislead drug safety professionals and cause the wrong conclusions to be drawn, in addition to myriad other issues, according to a report from the Tufts Center for the Study of Drug Development released Wednesday. Background FDA has three adverse event reporting forms it uses to collect data on drugs (prescription and non-prescription), biologics, m...
  • Regulatory NewsRegulatory News

    US FDA Proposes Changes to MedWatch Program for Healthcare Products

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products. The Food and Drug Administration is seeking comment through July 1, 2015 on  changes  to three reporting components of its MedW...
  • Regulatory NewsRegulatory News

    FDA Proposes Changes to its Adverse Event Reporting Forms

    The US Food and Drug Administration (FDA) is proposing several changes to its adverse event reporting forms, known within the industry as Forms 3500, 3500A and 3500B. Background FDA has three adverse event reporting forms it uses to collect information about medical products, including drugs (prescription and non-prescription), biologics, medical devices and dietary supplements. Form 3500, which healthcare providers can use to report information on a voluntary basis ...
  • FDA Testing Confirms Fungal, Bacterial Contamination of Yet Another Pharmacy's Products

    US Food and Drug Administration (FDA) officials yesterday confirmed what they have feared for more than a week: Products from yet another pharmaceutical compounding pharmacy are contaminated with fungal and bacterial growth. Background Compounding pharmacies have been subject to enhanced scrutiny by FDA in recent months, resulting in a huge number of Warning Letters, Form 483s, recalls and general warnings to consumers and healthcare providers. The root of this enhance...
  • New Medwatch Form Geared Toward Simple Adverse Event Reporting for Consumers

    The US Food and Drug Administration (FDA) is touting the 20 th anniversary of one of its most essential safety reporting tools, MedWatch, which it uses to collect adverse event reports about pharmaceuticals, medical devices and other FDA-regulated products, allowing it to monitor risks to consumers and take action when necessary. And now FDA is announcing something else: a consumer-focused MedWatch reporting form. Background In a 3 June 2013 posting on FDA's Voice bl...
  • Disturbing Parallels Seen in New Compounding Pharmacy Warning

    US regulators have issued a warning regarding products compounded at a Tennessee pharmacy, saying that it was aware of at least seven adverse events potentially associated with supposedly sterile steroid injectable products manufactured by the company, drawing close parallels to an outbreak that occurred in October 2012. Background Compounding pharmacies have been subject to enhanced scrutiny by FDA in recent months, resulting in a huge number of Warning Letters, Form 4...
  • Non-Proprietary Name Confusion Leads to Safety Warning for New Breast Cancer Drug

    What's in a name? While Shakespeare tells us that a rose by any other name would smell just as sweet, a newly approved drug is finding out that a similar-sounding non-proprietary name has the potential to cause some very sour problems in the form of potential mix-ups and safety problems. The drug in question is Kadcyla (ado-trastuzumab emtansine), a new breast cancer therapy for patients with HER2-postive, metastatic breast cancer that did not respond to prior treatments...
  • Study: FDA Recall Communication System Ineffective, Poorly Designed

    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 number of recall notices itself, says a new study. The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products ...
  • FDA, ISMP Announce New Initiative to Reduce Medication Errors

    The US Food and Drug Administration (FDA) announced Monday (2 April) it has formalized an existing relationship with the Institute for Safe Medication Practice (ISMP) to help protect consumers from medication errors. ISMP, a Pennsylvania-based non-profit, is focused on ways to prevent medication errors through making changes to labeling, packaging, prescribing, dispensing and other communications in the dispensing process. ISMP already operates a national Medication Err...