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  • Regulatory NewsRegulatory News

    Top Ten Stories From 2016 by Traffic

    Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading! Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers : A perennial favorite, this explainer breaks down the latest in the lucrative world of PRVs. Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017 :...
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    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
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    FDA Offers First Major Update to ‘Orange Book’ Website

    The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.” FDA's Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another, while FDA's Purple Book is list of all licensed biologics and biosimilars (the biological equivalent of the phar...
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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...
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    Updated: UK Company Banned From Shipping Medical Devices to US

    [ Editor's note from 2/25/16: This article has been updated with comment from Bedfont. ] The US Food and Drug Administration (FDA) has added UK-based Bedfont Scientific to its import alert list for medical device companies that have not met device quality system requirements. Bedfont is now banned from shipping its products to the US, which includes its breath test monitors, nitric oxide and carbon monoxide monitors, and medical pipeline testing equipment. “Foreign ...
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    FDA Allows Banned Chinese Firm to Ship Chemotherapy to US as Shortage Threat Looms

    [Editor's note on 2/19/16: FDA spokesman Stephen King has since offered additional comment though he could not confirm whether or not this comment applies to Zhejiang Hisun or what the company has done to ensure that the API it's allowed to send to the US is not manufactured in the same way as the APIs that are banned from entering the US .  "When FDA exempts certain drugs from an import alert due to shortage concerns, the agency also often requests the manufacturer to ...
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    CDRH Bans Imports From Australian Company for Failing to Meet Quality System Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) added Australia’s TFS Manufacturing to a list of medical device manufacturers that have not met device quality system requirements. TFS says it manufactures a tissue fixation system that “repairs organ prolapse by tensioning the ligaments and bringing laterally displaced connective tissue structures, such as ligaments and fascia, together. It combines soft tissue anchors with ...
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    Updated Again: FDA to Pull Singapore Device Firm From Import Alert List

    A subsidiary of Biosensors International, a group of companies developing, manufacturing and marketing medical devices for cardiology and critical care procedures, failed to respond to an inspection request from the US Food and Drug Administration (FDA) and its products were banned from entering the US. However, five days after the company's name was posted on the import alert list, a Biosensors spokesman told  Focus  that the company will be removed from the list aft...
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    Importers of FDA-Regulated Products Prepare for February Shift to Automated System

    In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade. As of 28 February, 2016, all importers and brokers of FDA-regulated products will have to submit entry data through the new Automated Commercial Environment (ACE). And by t...
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    Three Asian Companies Banned From Sending Imports to the US by FDA

    China-based Jinan Jinda Pharmaceutical Chemistry Co., Zhejiang Qianfei Enterprise Co. and Hong Kong-based Chan Yat Hing Medicine Factory were added to the US Food and Drug Administration’s (FDA) import alert list over the last two weeks, effectively banning the companies from shipping products to the US. FDA has now added 21 new companies to its import alert list in 2015, with companies listed from Canada (1), China (4), Czech Republic (1), Denmark (1), Hong Kong (1), In...
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    FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company

    The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US. CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website . The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name. The updated FDA import alert...