• Regulatory NewsRegulatory News

    FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices

    The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs). The Merlin@home device is used to communicate with a range of St. Jude's ICDs, including its radio frequency-ena...
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    Electronic Informed Consent: Final Q&A Spells Out New Recommendations

    The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products. The guidance focuses on procedures to be followed when using electronic informed consent (eIC) to help: Ensure prote...
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    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
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    EC Seeks to Update Scientific Opinions on Non-Human Primate Research, Safety of Breast Implants

    The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on Friday announced that it’s seeking more information to update its scientific opinions on the need for non-human primate research, production and testing of drugs and devices, and whether to update its opinion on the safety of PIP breast implants and the possible link between breast implants and a rare cancer. The review of using primates for biomedical research comes as...
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    Swedish Regulators Find Capsugel’s Oregon Site Not GMP Compliant

    Sweden’s Medical Products Agency (MPA) declared Monday that Capsugel subsidiary Bend Research’s Oregon manufacturing site does not comply with Europe’s good manufacturing practice (GMP) requirements. The statement of non-compliance follows a 24 February inspection of the site, which uncovered non-compliant operations with regard to non-sterile products, packaging and quality control testing. The inspection also found two critical, seven major and 12 other deficiencies ...
  • Feature ArticlesFeature Articles

    Drug Development in Asia: Scattering the Mist

    This article discusses misconceptions and their causes, surrounding drug development in Asia, and explains the regions current drug development landscape. Introduction Asia is a huge landmass with contrasting physical and human geographies. The economic panorama within this rich milieu of human geography has become one of Asia's most prominent features, and many major pharmaceutical companies are acquainting themselves with the unique regulatory and medical landscape ...
  • RAPS' LatestRAPS' Latest

    RAPS Launches Global Survey of Regulatory Professionals' Work and Compensation

    RAPS has just launched its biennial global survey of regulatory professionals who work with healthcare and related products. RAPS’ Scope of Practice & Compensation Survey of the Regulatory Profession , conducted every two years, is the largest and most comprehensive survey of professionals in this important field, vital to ensuring healthcare products are safe and effective. Respondents work in the pharmaceutical, biotechnology and medical device industries, governme...
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    FDA Warns Heater Cooler Maker Over Cleaning Instructions

    The US Food and Drug Administration (FDA) issued a warning letter to medical device maker LivaNova (formerly Sorin Group) for inadequately validating and verifying certain processes intended to clean and disinfect the company's Heater Cooler 3T devices. Because of the violations FDA says it is "taking steps to refuse entry" of devices made at LivaNova's Munich facility until the company addresses the violations. The agency also says that some of the changes in recent ver...
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    CBER Touts Performance, Contributions to Public Health in FY2015

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) says it met or exceeded its performance goals for FY2015, according to a new report. Notably, the FY2015 Report from the Director will be the last under CBER Director Dr. Karen Midthun's leadership. Midthun is set to retire at the end of 2015, ending her 22 year career at FDA. As in previous years, CBER met or exceeded the performance goals for product reviews established b...
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    Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act

    Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate. The provisions in question would add an additional six months of marketing exclusivity for approved drugs that later go on to be approved to treat rare diseases. The extended period of exclusivity would apply to all indicati...
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    India’s CDSCO Offers Four New Updates to Promote Clinical Research

    India’s Central Drugs Standard Control Organization (CDSCO) issued four new circulars on Tuesday that all seek to help promote clinical research on the subcontinent. The new circulars come as pharmaceutical research in India has been on the decline in recent years. CDSCO approved 19 trials through the first four months of 2015, which compares with 76 trials approved through the first five months of 2014, and 24 approved over the same time in 2013. Academic Research ...
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    India Unveils New Guidelines for Clinical Research Involving Children

    India for the first time in its history has released comprehensive guidance related to the ethical specifics of biomedical research in neonates and children. The pragmatic guidelines from the Indian Council of Medical Research (ICMR) set out general principles that can be applied in most situations to cover the ethical and legal issues that researchers need to consider when carrying out such biomedical research. General Guidance First and foremost, the guidance calls f...