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    FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility. The warning letter comes after a four-day inspection of the facility last May that resulted in FDA placing the firm on import alert in late June. During the inspection, FDA says its investigator "observed rodent feces throughout [the] facility," incl...
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    ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

    The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection. ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemen...
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    FDA Looks to Standardize PQ/CMC Data and Terminologies

    The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...
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    FDA Warns Chinese API Maker for Data Integrity Issues

    The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year. Background In March, FDA placed Qinhuangdao on import alert as a result of the inspection findings, an action that raised alarms at the World Health Organization (WHO), as the company is the only prequa...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
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    FDA Warns Two Drugmakers in China and India for Data Integrity Violations

    The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year. Data integrity has been a growing area of focus for FDA, with an increasing number of warning letters and Form 483s citing data integrity violations, many for manufacturers in China and India. USV Warning Let...
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    European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...
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    FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance

    The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues. In a warning letter dated 17 February, FDA details six violations uncovered during a month-long inspection of the Morton Grove, Illinois facility in January and February 2016. In 2014, FDA issued the site a Form 483 detailing 12 observations covering product testing, recordkeeping and data integrity issues. In a filing ...
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    FDA Warns Megafine Over Data Integrity Violations at Second Facility

    The US Food and Drug Administration (FDA) last month warned Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma Ltd. over data integrity and manufacturing violations at its Gujarat, India facility. The warning letter comes after FDA inspected the Gujarat facility over the course of five days last September, and less than a year after the agency warned Megafine for a host of data integrity violations at its other facility in Maharashtra, India tha...
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    FDA Warns China API Manufacturer for Data Integrity Violations

    The US Food and Drug Administration (FDA) in late February warned Fosun Pharmaceutical subsidiary, the formerly Chinese state-owned Chongqing Pharmaceutical Research Institute (CPRI), over data integrity issues. The warning letter comes after a four-day inspection of CPRI's active pharmaceutical ingredient (API) and contract research and manufacturing facility in Chongqing, China last May. During the inspection, FDA says it found evidence the company was habitually del...
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    FDA Officials Defend Agency's Flexibility Under Current Regulatory Framework

    Top officials at the US Food and Drug Administration (FDA) are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions. In an article in Nature Reviews Drug Discovery on Friday, Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, writing alongside former FDA Commissioner Robert Califf and other high-ranking agency officials, argue ...
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    21st Century Cures Act Deadlines Approach in March and June

    The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March. Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) inc...