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    FDA Warns Three Companies Over DTC Genetic Tests

    Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests. The letters are addressed to three companies: DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., which FDA says are marketing genetic tests to consumers without being cleared. In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnost...
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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...
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    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...
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    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 ....
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    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...
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    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...
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    India’s CDCSO Establishes New Testing Requirements for Blood Glucose Strips

    India’s Central Drugs Standard Control Organization (CDSCO) is looking to tighten the regulation of blood glucose testing supplies, it announced last week. In a 7 August 2014 notice issued to all local State Drugs Controllers and port authorities, CDSCO ordered that importers and manufacturers of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida.  Following the testin...
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    Usability and Self-Selection Trials – Clinical Studies of Human Factors

    Introduction Most clinical trials conducted for US Food and Drug Administration (FDA)-regulated medical devices are focused on two key objectives: safety and effectiveness. These studies are designed to help determine whether a device is able to meet its performance claims and to detect any potential risks, side effects or precautions that should be included in the product labeling. However, a unique challenge rarely found in the realm of pharmaceuticals exists for a med...
  • FDA Tightens Limits on Endotoxin Testing for Some Eye Surgery Devices

    The US Food and Drug Administration (FDA) is warning manufacturers of intraocular ophthalmic devices that they must do more to reduce the risk of their devices being contaminated with the endotoxins which cause Toxic Anterior Segment Syndrome (TASS) outbreaks. The warning came in the form of a new draft guidance document, Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices , released on 17 April 2014. The guidance notes that national outbr...
  • New FDA Guidance Aims to Better Assess Side Effects of Low Molecular Weight Heparins

    Patients being treated with low-molecular weight heparins-anticoagulants used to prevent and treat blood clots-are susceptible to potentially fatal adverse events known as heparin-induced thrombocytopenia ( HIT ). A new guidance document published by the US Food and Drug Administration (FDA) hopes to better warn patients of those risks through strengthened testing requirements. Background As FDA explains in its new guidance document, Immunogenicity-Related Consideratio...
  • Brazil's Anvisa to Assess Alternatives to Animal Testing

    The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) has instructed the agency to review all regulations that require the submission of data from animal experiments to support marketing applications in order to determine situations where it would be possible to use alternative validated testing methods.  The agency is encouraging the development of alternative methods to animal testing through the Brazilian Centre for the Validation of Alterna...