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  • Regulatory NewsRegulatory News

    FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices

    Under a US Food and Drug Administration (FDA) contract, a new rubric developed by the Mitre Corporation is the first-of-its-kind to be specifically tailored to medical devices, and is set to take the form of a medical device development tool (MDDT) to ensure consistency in scoring cybersecurity risks. The common vulnerability scoring system (CVSS) open standard for assessing software vulnerability severity has seen widespread use on an international scale since its 2005...
  • Regulatory NewsRegulatory News

    European Commission Offers New Q&A on Biosimilars

    The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars. Similar to the Focus  explainer on biosimilars , the 9-page EC explainer, available in seven languages, offers a quick 10,000-foot view of the biosimilars landscape, answering questions that patients might have on what a biologic is, what a biosimilar is, how biosimilars compare to generics, what types of studies biosimilars must undergo pri...
  • Regulatory NewsRegulatory News

    Cancer Immunotherapies: EMA to Hold November Workshop

    The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria). As EMA explains, “Immunotherapy is a type of cancer treatment that mobilizes the body's own defense mechanisms to fight cancer. Immunotherapy m...
  • Regulatory NewsRegulatory News

    FDA Discusses How to Regulate NGS Tests for Cancer Diagnoses

    The US Food and Drug Administration (FDA) is seeking input on how to regulate next-generation sequencing (NGS) tests that can scan a tumor's genes to guide cancer treatments. At a public workshop at FDA's campus in Silver Spring, MD on Thursday, experts in oncology and NGS discussed some of the challenges and considerations for establishing standards for validating what's known as NGS-based oncology panels or assays. In recent years, increased understanding of genetics ...
  • RAPS' LatestRAPS' Latest

    Chicago Workshop to Help Regulatory Pros Communicate More Effectively

    Most regulatory professionals do not have a background—or often any training at all—in communications. Yet they are called upon every day to be effective communicators. Whether it’s communicating with their peers on a regulatory team, colleagues in other areas within their organizations, upper management, regulators, researchers, contractors or others, regulatory pros need to be clear, establish credibility and influence people in different disciplines and at many d...
  • RAPS' LatestRAPS' Latest

    FDA Expresses Desire to Work With Industry on CGMPs for Combo Products

    During RAPS’ and the Combination Products Coalition’s (CPC) recent workshop on current Good Manufacturing Practice (CGMP) for combination products, which took place on 1 April, the US Food and Drug Administration’s (FDA) lead presenter, John Barlow “Barr” Weiner, paused briefly to acknowledge the date’s popular connotation. “I just realized I should’ve inserted some sort of April fools [joke] in this presentation,” said Weiner, who is the associate director for polic...
  • Regulatory NewsRegulatory News

    How Should FDA Regulate Lab-Developed Tests? Agency Wants to Know

    The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...
  • Regulators, Industry Prepare to Dig into Liver Toxicity Concerns in Bid to Improve Safety

    A meeting proposed by US regulators would again seek to bring together the US Food and Drug Administration (FDA), pharmaceutical trade industry group PhRMA, the regulatory science-focused Critical Path Institute and public stakeholders to discuss best practices for detecting and assessing the likelihood that pharmaceutical products cause liver damage in patients. Background Liver toxicity, sometimes referred to as hepatotoxicity, is a serious but relatively c...
  • As Intraocular Lenses See Technological Evolution, FDA Looks to Reassess Clinical Evaluation Methods

    The US Food and Drug Administration (FDA) has announced it plans to hold a joint workshop with the American Academy of Ophthalmology (AAO) to address challenges that affect the regulatory assessment of innovative intraocular lenses (IOLs). Background IOLs are-as their name implies-lenses that are physically implanted into the eye, most often to treat medical conditions like cataracts which otherwise disrupt the body's own crystalline lens. FDA's Federal Register noti...
  • FDA Looks to Harmonize Standards for Cellular, Regenerative Therapies

    The US Food and Drug Administration (FDA) has announced it will soon hold a workshop with the intent of discussing the development of "synergized" standards for cellular therapies and regenerative medicine products, saying current standards run the risk of becoming disharmonized. Background Regenerative medicine is, as its name implies, the emerging scientific field associated with the idea that cells, tissue, organs and even entire body parts can be regenerated, restor...
  • EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward

    EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication errors. That workshop , held in February 2013, brought together regulators across the EU in the hopes of raising awareness around new legal requirements for reporting medication errors and to generate best practices for EU regional regulators. Those errors, as defined by the a...
  • Are Medical Devices Meeting the Needs of Women?

    The US Food and Drug Administration's (FDA) device regulatory division wants to know: Are medical devices meeting the unique needs of women? That question is behind a newly announced workshop the agency's Center for Devices and Radiological Health (CDRH) plans to hold in June 2013 entitled, "The Health of Women (HoW) Program: Educate, Enable, Enlist and Explore-HoW to Improve the Health of Women." Background FDA has in the last two years announced at least one initiati...