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  • Regulatory NewsRegulatory News

    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
  • Regulatory NewsRegulatory News

    FDA: Lead Test Company May Have Violated Federal Law

    The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems. FDA cited the issues in a 10-page inspection report stemming from a month-and-a-half long inspection of Magellan's North Billerica, MA facility from 10 May to 29 June 2017. A week into that inspection, FDA warned the public that all four of Magel...
  • Regulatory NewsRegulatory News

    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...
  • Regulatory NewsRegulatory News

    FDA Revises Guidance on Safety Testing of Drug Metabolites

    The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The revisions mean the new guidance supersedes guidance from February 2008. The guidance has been revised to be in alignment with ICH guidance, known as M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authori...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission

    The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT). Specifically, FDA says that HCT/P establishments should add nucleic acid tests for HBV to their testing arsenal as the new tests offer significant improvements in how early the virus can be detected. "FDA-licens...
  • Regulatory NewsRegulatory News

    Rodent Carcinogenicity Testing: Changes to ICH Guidance Proposed

    The European Medicines Agency (EMA) is considering changes to International Council for Harmonisation (ICH) guidance on rodent carcinogenicity testing to improve the evaluations, reduce use of animals and drug development resources and reduce timelines to market authorization in some cases without compromising patient safety. The goal of the potential changes to the S1 guidance, according to EMA, is to introduce a better way to address the risk of human carcinogenicity o...
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    FDA Proposes to Exempt Some Genetic Screening Systems from Premarket Requirements

    The US Food and Drug Administration (FDA) has decided to look into exempting from premarket requirements some genetic screening systems that can test parents for specific conditions they could possibly pass down to their children. The possible exemption of the autosomal recessive carrier screening gene mutation detection systems, which are Class II devices, would help companies bring to market systems that can test parents for specific genetic conditions, such as cy...
  • Regulatory NewsRegulatory News

    European Commission Responds to 'Stop Vivisection' Campaign

    The European Commission (EC) has responded to a campaign calling for an end to animal testing in the EU, saying animal testing is still necessary, but promising to accelerate efforts to reduce the need for animal testing. Background In March 2015, the Stop Vivisection campaign submitted a European Citizens' Initiative to the EC, calling for the commission to repeal Directive 2010/63/EU and replace it with new legislation that would phase out animal testing. A Eu...
  • Feature ArticlesFeature Articles

    Magnetic Resonance Safety Testing and Labeling for Devices

    Traditionally, all Magnetic Resonance (MR) scanner systems have included a contraindication for patients with metallic implants. General practice was to not scan patients with implants in ordinary facilities, but only at more-sophisticated MR facilities under carefully monitored and controlled conditions. Since then, Magnetic Resonance Imaging (MRI) has become the standard of care for diagnosing many conditions, such as cancer, neurological diseases and orthopedic disord...
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    New Bill Would Reduce FDA Burden on Research-Use Devices

    A new bill introduced in the House of Representatives by a prominent Republican legislator would make it easier for companies to distribute investigational medical devices explicitly labeled as being "for research use only (RUO)." The Medical Testing Availability Act of 2015 , sponsored by Rep. Michael Burgess (R-TX), the vice chairman of the Energy and Commerce Committee's Subcommittee on Health, is similar to an identically titled bill introduced by Burgess in 2013 ....
  • Regulatory NewsRegulatory News

    FDA Cancels Study of How it Can Use Drones to Conduct Inspections

    The US Food and Drug Administration (FDA) is no longer considering the use of aerial drones to help assist its on-site inspections of facilities, less than 24 hours after initially saying feasibility studies were in the works. As first reported by Regulatory Focus , on 16 December 2014 FDA sent an email to staff indicating that it planned to test the use of drone technology for its potential applications "in the areas of manufacturing site inspections, farm inspection...
  • Regulatory NewsRegulatory News

    India’s CDSCO Reduces API Stability Testing Data Requirement

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) issued a  notice  on 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three ba...