This article compares real-world evidence (RWE) and postmarket surveillance (PMS) data collected outside of a randomized, controlled, clinical trial. Real-world data (RWD) include individual patient data points such as complaints and anecdotal findings. The recent explosion in RWD collection has led to new challenges in RWD evaluation globally. Solutions are rapidly evolving to analyze these relatively random data points for scientifically valid purposes. This article disc...

The International Council for Harmonization (ICH) announced on 29 April the release of its first set of data maps with SNOMED International that facilitates the exchange of adverse event reports and other important epidemiologic information between regulators and researchers.   This release of the maps is the first deliverable of an agreement between SNOMED International and ICH that aims to promote drug safety. The ICH Medical Dictionary for Regulatory Activities (...

As part of efforts to make breast implants safer, the US Food and Drug Administration (FDA) should consider additional postmarket data reporting requirements on breast implant manufacturers, the agency’s General and Plastic Surgery Devices Panel suggested after a two-day meeting. On whether to remove textured breast implants from the US market as other countries have done, the panel argued data is lacking to support such a recommendation as it would reduce options for p...

The US Food and Drug Administration (FDA) sent a letter to health care providers Friday over a growing body of adverse events associated with surgical staplers and implantable staples.   The agency’s ongoing analysis of medical device reports (MDRs) found that it received more than 41,000 individual MDRs that describe adverse events associated with the use of surgical staplers and staples for internal use between 1 January 2011 and 31 March 2018.   These include 36...

The US Food and Drug Administration (FDA) sent a letter to health care providers on Wednesday to raise awareness on additional cases of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). The letter addresses the last update on medical device reports (MDRs)—otherwise known as adverse event reports—submitted to FDA’s Center for Devices and Radiological Health (CDRH) regarding BIA-ALCL. The September 2018 update reported on a total of 660 MDRs of BIA-ALCL...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines Australia’s Therapeutic Goods Administration (TGA) has finalized its timelines for reporting adverse events involving biologicals. The timelines are unchanged from draft guidance published last year that was criticized by companies including Pfizer for giving sponsors too little time to act. Un...

This article discusses past and present congressional legislation and FDA regulations pertaining to reporting dietary supplement adverse events. It also focuses on the value of post-market surveillance to protect consumers and defines and clarifies the regulatory professional's role in communicating product safety as technology continues to expand data access. Introduction Current laws regarding Dietary Supplement (DS) regulation by the US Food and Drug Administration...

With the 22 November launch date for its revamped EudraVigilance system rapidly approaching, the European Medicines Agency (EMA) on Wednesday provided some last minute updates on what to expect during the transition to the new system. New EudraVigilance System The new system, developed in response to changes brought on by the EU's pharmacovigilance legislation that went into effect in 2012, promises to improve adverse event reporting and safety monitoring. Specifical...

The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics. Known as FAERS (FDA's Adverse Event Reporting System), the database contains some 14 million adverse event reports submitted to FDA by healthcare professionals, consumers and manufacturers for drugs and biologics. Its immediate release led to questions over certain deaths , whether they were linked to the drug's safety...

A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions. In a paper appearing in eLife earlier this month, the researchers say such changes could help address several major challenges to interpreting data in FDA's adverse event reporti...

With the rise of Right-to-Try legislation across states in the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA). But a new Government Accountability Office report released Tuesday lends credence to many who have voiced concerns with the Right-to-Try laws,...

Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs). "Reports about serious ADRs and MDIs can be important signals of emerging safety issues. Such post-market observations can also lead to improved safety information about a product," ...