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  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    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 The warning came in the form of a new draft guidance document, Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices , released on 17 April 2014.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...
  • New Warning Letters to Indian Manufacturers Again Find CGMP Violations, Falsified Test Results

    Another batch of Warning Letters made public by the US Food and Drug Administration (FDA) has brought still more negative attention toward Indian pharmaceutical manufacturers, with issues that mirror recent letters and include falsification of records and failure to assure product sterility. Background Indian manufacturers have been the focus of intense scrutiny in recent months following a major court case involving Indian manufacturer Ranbaxy, in which it pleaded gu...
  • Brazil Suspends Certification Process for Foreign Bioequivalence and Bioavailability Test Centers

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has suspended processing of new applications for primary certification of bioavailability or bioequivalence for medical products by research centers located outside the country. Applications filed prior to 31 July 2013, the date the suspension entered into force (RDC 37/13), will still be processed, regulators said. The purpose of the suspension is to facilitate the review of existing rules governing foreig...
  • FDA Cracks Down on Indian Manufacturers, Citing New FDASIA Authority and Egregious Violations

    In the wake of a disturbing regulatory investigation against Indian manufacturer Ranbaxy, in which regulators determined that the company had routinely falsified and altered testing results-determinations that later resulted in a massive $500 million fine against the company, the largest in history-the US Food and Drug Administration appears to be cracking down hard on other Indian manufacturers for similar discrepancies. The Start of a Crackdown? The first hint of th...
  • Warning Letter to Wockhardt Details Extraordinary Failures, Efforts to Deceive FDA Inspectors

    Indian pharmaceutical manufacturer Wockhardt has not had an easy few months. A March 2013 inspection by the US Food and Drug Administration (FDA) resulted in an import alert for products manufactured at the company's Waluj, Aurangabad facility, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a massive recall for products manufactured at the same facility. Clearly, something at the facility was amiss-something confirmed by the India Times ...
  • Investigation of Indian Manufacturer Finds Deficient Testing Practices, Falsified Records

    A Warning Letter sent by the US Food and Drug Administration (FDA) to an Indian pharmaceutical manufacturer alleges that the company routinely repeated tests when initial testing did not give it the desired results and, in at least one case, improperly back-dated results. The 28 May 2013 Warning Letter references two inspections conducted by FDA, one in November 2012 of RPG Life Sciences' Ankleshwar, Mumbai facility and the other a January 2013 inspection of its Navi, ...
  • How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

    What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon have a private-sector solution to improve their ability to ensure their medicines are of sufficient quality and identity. That initiative, run by the Partnership for Safe Medicines India Initiative (PSMII), is a side project of the Partnership for Safe Medicines-a coalition ...
  • EMA in Midst of Website Overhaul, Calls for Industry Assistance

    The last decade has seen an increasing shift into digital forms of communication, submission and information in the regulatory affairs space. Sponsors can now submit applications and submit updates to regulators electronically, and-perhaps most importantly-find the regulations and guidance documents they need online instead of in a library or legislative building. But as those layers have built over time, it has become exceedingly difficult for a sponsor to find the exact...