• Regulatory NewsRegulatory News

    FDA Warns, Blocks Imports From Chinese API Manufacturer

    Earlier this month, the US Food and Drug Administration (FDA) sent a warning letter to a Hubei, China-based active pharmaceutical ingredient (API) manufacturer related to several failures. The letter issued to Hubei Danjiangkou Danao Pharmaceutical Co. notes the company’s failure to demonstrate that its manufacturing process can reproducibly manufacture an API meeting predetermined quality attributes, a failure of its quality unit to approve changes that potentially...
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    Lupin Warned by FDA for Deficiencies at Two Facilities

    The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India. Lupin acknowledged receiving the warning letter in a Bombay Stock Exchange filing on 7 November, saying it had responded to nine observations stemming from FDA's inspections and that it will work to address the concerns raised in the warning letter. The warning letter says Lupi...
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    FDA Warns Chinese Firm for Confusing API in OTC Drug

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs the firm made was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate. The company told FDA that the mix-up is the result of "a translation mistake," according to the warning letter...
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    FDA Warns Four Companies Selling Cannabidiol Over Unproven Claims

    The US Food and Drug Administration (FDA) on Wednesday warned four companies selling cannabidiol (CBD) containing products for making claims that their products can treat or cure cancer and other diseases, including Alzheimer's, arthritis, heart disease and stroke. "Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act , but also can put patients at risk as these products have not bee...
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    Meeting With FDA After a CRL: Draft Guidance on What to Expect

    The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies. The guidance, released as part of the agency's second Generic Drug User Fee Amendments (GDUFA II) commitments, offers details for companies on what a meeting request should include, how the requests will be assessed, ...
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    FDA Warns Swedish IVD Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II  in vitro  diagnostic (IVD) devices. The warning, following an inspection last January, features at least five violations, including one related to the company’s decision to not recall an assay used to detect anti-nuclear antibodies after receiving complaints of a higher incidence of false p...
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    FDA Warns Korean Drugmaker Over Testing, GMP Issues

    The US Food and Drug Administration (FDA) has warned South Korean drugmaker Dasan E&T Co. Ltd. over product testing issues following an inspection of its Gimpo, Kyonggi-do facility in January. In a warning letter released on Monday, FDA says the company failed to adequately test its raw materials and finished products to ensure they conformed to appropriate specifications. "Your firm failed to analyze glycerin raw material from your supplier prior to the quality unit re...
  • Feature ArticlesFeature Articles

    FDA Enforcement Trends for Broadcast Advertisements

    This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information. Introduction From January 2016 through Augus...
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    FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors

    The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May. According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US. In another instance, FDA says the firm reported that a batch of one of its products was within specification ...
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    FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components

    The US Food and Drug Administration (FDA) on Tuesday warned Pfizer subsidiary Meridian Medical Technologies for failing to adequately investigate faulty components used to make EpiPen and EpiPen Jr auto-injectors for Mylan. The warning letter comes less than six months after Meridian recalled 13 lots of EpiPens over concerns that a defective part could prevent the injectors from activating properly, and after a month-long inspection of Meridian's Brentwood, MO facility...
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    FDA Warns Drugmaker Over Opioid Marketing Materials

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has warned Canadian drugmaker Cipher Pharmaceuticals over promotional materials for its combination immediate and extended release opioid ConZip (tramadol hydrochloride). The warning letter, only the second sent from OPDP in 2017, comes as the US grapples with an ongoing opioid epidemic that has brought increased scrutiny on opioid makers and their marketing practices. According to ...
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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...