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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...
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    Transparency Push: EMA to Revise Policy on Document Access

    The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals. Since October 2016, EMA has published pharmaceutical trial data via its new website , including for: Mylan's aripiprazole, published most recently on 31 January 2017, Pfizer subsidiary Hospira's palonosetron, Praxbind  (idarucizumab), Tarcev...
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    CDRH Warns Three Foreign Medical Device Manufacturers

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea. Among other violations, the warning letter for Taiwan-based HMD Biomedical, which manufactures GoodLife AC 300-305 Self-Monitoring Blood Glucose, says the company did not establish and maintain procedures for validating the device’s design, nor did it provide trainin...
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    FDA Warns One Japanese, One Chinese Drugmaker

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month. Sato Yakuhin Kogyo In its warning letter to Sato Yakuhin Kogyo, FDA cites the company for data integrity issues and failing to investigate out-of-specification test results uncovered over a five-day inspection of the company's Kashihara City, Japan facilit...
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    FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

    Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. The 18-page guidance is one in a series implementing the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that established a pathway for the approval of such follow-on biologics. Four other final guidance documents and two o...
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    EMA to Launch Tailored Biosimilar Scientific Advice Pilot

    The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars. The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard  scientific advice  does not include the assessment of existing data). EMA plans to run the pilot until ...
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    FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices

    The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA). Under the guidance, FDA will issue more prompt notifications to the public about medical device "emerging signals," including information that supports a new causal association or a new aspect of a known association between a device and an adverse event, or new information determined by FDA to h...
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    FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’

    Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible." Defining RWE Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, wr...
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    FDA Warns Japanese API Maker Over Data Integrity Issues

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Japanese active pharmaceutical ingredient (API) maker Sekisui Medical Co., Ltd. for a series of data integrity issues at the company's Iwate, Japan site. Data Integrity Data integrity issues have been a growing concern for regulators in recent years. In 2016, both FDA and the European Medicines Agency (EMA) released new draft guidance for industry detailing their expectations for ...