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  • Regulatory NewsRegulatory News

    FDA official: Growing number of enforcement actions stem from inspection alternatives

    Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections.   So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in FDA’s Center for Drug Evaluation and Research (CDER) at a compliance and enforcement update at a 26 October...
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    FDA finalizes guidance on field alert reports

    The US Food and Drug Administration on Thursday finalized guidance on its expectations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in submitting field alert reports (FARs) for potentially defective drugs. It contains only minor changes from the draft.   The final document supersedes a draft guidance that was issued in July 2018. (RELATED: Field Alert Report Submissions: FDA Offers Draft Q&A , Regulatory Focus 19 Jul...
  • Feature ArticlesFeature Articles

    Third Party Certification for Drugs Associated With an Import Alert Exception

    The US Food and Drug Administration (FDA) has begun a widely recognized campaign of intensified surveillance of foreign manufacturers of Active Pharmaceutical Ingredients (APIs) and finished drug products. Failure to comply with the regulatory requirements for good manufacturing practice can subject a foreign firm to an import alert, thereby cutting off access to commercial distribution in the US. This article provides an overview of the consequences of an import alert a...
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    FDA Alerts on Risks From Merck’s Keytruda in Multiple Myeloma Following Halted Trials

    The US Food and Drug Administration (FDA) on Thursday released an alert and summary of findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. The immunotherapy Keytruda is approved by FDA for the treatment of melanoma, lung cancer and other cancers but it is not approved to treat multiple myeloma. On 3 July, FDA required that all patients in these two trials b...
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    FDA Offers Updated Form for Field Alert Reports

    The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program. Under federal regulations, sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) are required to submit FARs to FDA within three days of being alerted to a potential safety issue, such as a labeling mix-up or bacterial contamination. In May 2013...
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    FDA Warns B. Braun Medical’s California Plant for Repeat Violations

    The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015. FDA found in its latest inspection from 18 April to 11 May 2016 that B. Braun’s "quality unit was not effectively exercising its responsibilities, particularly for investigating product defect complaints, manufacturing deviations, and adverse t...
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    Democrats Revive Canada Drug Import Bill as Safety Questions Linger

    Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices. Sanders called the bill "critical" on Tuesday at a press conference, saying...
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    FDA Bans Imports of Piston Syringes From Nipro’s Thailand Site

    The US Food and Drug Administration (FDA) on Tuesday added Nipro’s Thailand site to a list of companies barred from shipping supplies of medical devices to the US because of a lack of quality. In this case, FDA will not allow shipments of Nipro Thailand’s piston syringes (with luer lock tip or catheter tip) into the US. Nipro Thailand is the only company or site to be listed on FDA’s Import Alert 89-17 list . “Under section 501(c) of the Federal Food, Drug, and Cosmeti...
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    Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Comprehensive Technical Guidance on Clinical Trials China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, walking drug developers through the entire clinical research process, from preparing to run a first-in-human trial to designing post-marketing and pharmacogenomic studies. CFDA has created the document to provide ...
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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 Continues Crackdown on Chinese Drug Manufacturers With new Warning for Xiamen

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs). As imports of pharmaceuticals from China and India have increased, so has FDA's enforcement of manufacturing for companies exporting to the US. In 2015, FDA carried out 132 inspections of Chinese manufacturers, more than twi...
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    Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US

    The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 ( GDUFA ). The companies include China’s Jiangsu ZW Pharmaceuticals Co. Ltd., which received a warning letter in 2015, and Wuxi Kaili Pharmaceutical Company, whi...