• Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA to Study Whether Consumers Can Take More Complicated Info in Pharma TV Ads

    As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...
  • Regulatory NewsRegulatory News

    Dr. Khoo Teng Chuan, Co-Chair of the RAPS Pan Asia Advisory Committee, Dies at 56

    Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56. Most recently, Dr. Khoo worked as chief medical officer for the Singapore Clinical Research Institute, after joining the institute as senior vice president in 2010. In this role as chief medical officer, he worked closely with Singapore’s national agencies including the National Medical Research Council, Health Sciences Aut...
  • Regulatory NewsRegulatory News

    What's in Store for the Medical Device Tax?

    Last month, the US House of Representatives passed a bill that would repeal the medical device tax levied under the Affordable Care Act ( ACA ). Now, the Senate Joint Economic Committee (JEC) has released a report critical of the tax, calling the tax "onerous" and "poorly conceived." Background The medical device tax has been controversial since before ACA was signed in 2010. Under ACA , a manufacturer or importer of a medical device is subject to an excise tax of...
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    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...
  • Regulatory NewsRegulatory News

    Company Challenges UK Clinical Trial Transparency Rules

    An initiative to increase clinical trial transparency in the UK is being challenged in court after a successful petition by a company that conducts clinical trials for the pharmaceutical companies, The Guardian reports. Background The Health Research Authority (HRA) is a recently launched branch of the UK's National Health Service (NHS), tasked with overseeing clinical research and making recommendations on how research is regulated. While HRA's main mandate is ...