• Regulatory NewsRegulatory News

    FDA Warning Letter Reveals Data and Sterility Issues at Teva Plant in Hungary

    The US Food and Drug Administration (FDA) on Tuesday released the warning letter it sent to Israel-based Teva Pharmaceuticals earlier this month, noting instances of data deletion and manipulation at the company’s manufacturing site in Gödöllő, Hungary. Last week, Teva disclosed in an SEC filing that it had received a warning letter on 14 October (four months after the site was banned from shipping products to the US), but now the details of that letter have revealed...
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    Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (25 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Clinical Data Probe Triggers Investigations Into 11 Trial Sites, CROs China’s Food and Drug Administration (CFDA) has opened investigations into 11 clinical trial sites and contract research organizations (CROs) as part of a data verification drive initiated last year. The regulator suspects the sites and CROs generated fraudulent clinical trial data to support 27 new ...
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    FDA Warns Teva’s Banned Hungary Manufacturing Facility

    The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program. The warning letter, sent on 14 October, followed FDA’s eight-day current Good Manufacturing Practices (cGMP) inspection of the facility, in January 2016. Teva said in an SEC filing that it “has undertaken corrective actions to address both the ...
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    Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Proposes Change to Rare Disease Threshold in Orphan Drug Rethink The Therapeutic Goods Administration (TGA) of Australia is proposing to change its definition of rare diseases as part of an overhaul of its orphan drug regulation. If implemented, the revised regulations will allow drugs that treat more common diseases to qualify for orphan medicine status, but only...
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    Standardization Best Practices for Managing Regulatory Processes: Part 1

    This article reviews the most common standardization challenges, including inconsistent data definition, data capture and processes and suggests system consolidation and automation will only succeed if data is standardized and processes are harmonized. Introduction In a three-part series, authors will share rich insights from research and explore identified challenges from a lack of standardization, manual processes and fragmented systems and offer practical advice an...
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    GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info

    Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data. The report, titled “FDA Needs to Rectify Control Weaknesses That Place Industry and Public Health Data at Risk,” offers 15 recommendations for FDA to fully implement its agency-wide information security program. For fiscal year 2015, the agency said it spent $58...
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    'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers

    The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations. In recent years, FDA has increased its level of oversight of overseas manufacturers, which has led to a greater number of warning letters being issued to such companies. So far in 2016, FDA's Office of Manufacturing Quality has issued 25 warning letters, 11 of which were...
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    CDRH Outlines Top 10 Science Priorities for 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for regulatory decisions, according to a list of its science priorities for 2017. As far as what will change between 2016 and 2017, the 13-page report says that thanks to more “needs submissions from staff,” CDRH was able to identify new topic areas, including clinical trial design and precision medicine, as well as desc...
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    EMA Official: Data Sharing and Collaboration Can Fill Scientific Gaps in Alzheimer's

    Speaking at a panel at RAPS' 2016 Convergence on Monday, Enrica Alteri, head of human medicines research and development support at the European Medicines Agency (EMA) called on drugmakers to share data to close the gaps in Alzheimer's disease (AD) research. According to Alteri, doing so could help the scientific community not only learn from past failures in Alzheimer's research, but enable the development and validation of new targets. Scientific Gaps "There are gaps...
  • ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join

    While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future. Paul Hargreaves, chair of PIC/S, explained to attendees at the P...
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    FDA Warns Pan Over Data Integrity, Sanitation Issues

    For the second time in less than a year, the US Food and Drug Administration (FDA) has issued a warning letter to Indian active pharmaceutical ingredient (API) maker Pan Drugs over data integrity and sanitation violations at one of its facilities. Due to the extent and repeat nature of the violations, FDA says Pan must carry out a comprehensive plan to investigate and address the issues. Data Integrity and Quality Control The warning letter, dated 25 August 2016, comes...
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    FDA Finalizes Guidance on Microbiology Data for Antibacterials

    The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health, with the World Health Organization (WHO) calling AMR "so serious that it threatens the achievements of modern healthcare." The threat is compounded by the fact that while bacteria are becoming in...