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    FTC Charges First Marketer of Intravenous Products

    The Federal Trade Commission (FTC) has, for the first time, charged a marketer and seller of intravenously injected therapy products, known as iV Cocktails, with making a range of “deceptive and unsupported health claims” about their ability to treat serious diseases. The proposed FTC order prevents the company, which operates clinics in Texas and Colorado, and its owner from making such claims unless they can be supported by competent and reliable scientific evidence. ...
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    FDA Releases ADMA Biologics Form 483 as Company Announces VAI Status

    The US Food and Drug Administration (FDA) this week unveiled a Form 483 from April for ADMA Biologics, a company that previously received a complete response letter related to manufacturing deficiencies. Earlier this month and prior to the 483’s release, however, ADMA said FDA’s inspection database classification website has been updated and “confirms ADMA’s compliance status has improved to Voluntary Action Indicated (VAI).” FDA explains the VAI designation as: “O...
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    Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

    Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals and FDA has released a third Form 483 for the company. Following inspections in July and August, FDA issued the 483 with 11 observations, with specific issues raised about the firm’s quality unit. “The system for managing quality to ensure confidence that the API [active pharmac...
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    Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

    Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday in draft guidance. According to FDA, the 8-page draft is meant to address four issues: How FDA’s centers identify whether responsible parties have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov or submitted false or misleading information to the data bank, and wheth...
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    End of the eCTD? FDA Pushes for New KASA System to Improve Assessments

    The US Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee met Thursday to discuss the positive aspects of adopting a Knowledge-aided Assessment & Structured Application (KASA) platform. As FDA Commissioner Scott Gottlieb discussed in June , the KASA platform aims to modernize generic drug reviews from a text-based to a data-based assessment. But Thursday’s discussion made clear that the KASA system may also be extended fo...
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    FDA Smashes Record for Most ANDA Complete Responses in one Year

    The US Food and Drug Administration (FDA) has issued more complete responses for abbreviated new drug applications (ANDAs) in 2018 than any other year, and the numbers are not even close. But the gap between this year and years past – 2,515 complete responses have been issued so far in 2018 vs. 1,603 in FY 2017 and 1,725 in FY 2016 – may be attributed to a spike in applications or other reasons. David Gaugh, senior vice president of sciences and regulatory affairs at...
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    DSCSA: FDA Finalizes 2 Guidances and Offers New Draft Q&A

    With an aim to offer more guidance on the Drug Supply Chain and Security Act (DSCSA), the US Food and Drug Administration (FDA) on Wednesday finalized two guidances and drafted a question and answer document on product identifiers. The guidance follows FDA’s decision to delay by one year – until 26 November – its enforcement of the requirement for manufacturers to affix or imprint product identifiers. One of the final guidances, based on a draft issued in July 20...
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    FDA Warns Mexican OTC Drugmaker, Dutch Drugmaker, San Francisco Device Company

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent recently to Jalisco, Mexico-based over-the-counter (OTC) drugmaker Jabones Y Productos Especializados, Netherlands-based drugmaker Fagron BV’s Minnesota manufacturing site and San Francisco-based ITG-MEDEV, Inc. Jabones Y Productos Especializados The company was cited by FDA for four violations following a three-day inspection in March. Among the violations was the company’s failure ...
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    Data Integrity a Top Concern for Manufacturers, FDA Says

    When a pharmaceutical or active pharmaceutical ingredient manufacturer has data integrity issues, that’s likely the tip of the iceberg, Sarah Barkow, of FDA’s Office of Manufacturing Quality, told attendees of the Pharma and Biopharma Outsourcing Association’s annual conference in Rockville, MD. “You need to worry about [data integrity] from all levels of the supply chain,” she said. “Once there are data integrity lapses, you know there are other things you don’t know.”...
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    PhRMA, AdvaMed, AAM Support FDA’s Proposed GMP Alternatives for Combo Products

    Industry groups PhRMA, AdvaMed and the Association for Accessible Medicines (AAM) have pledged their support for and sought further clarity on the US Food and Drug Administration’s (FDA) flexible ways by which combination products can comply with good manufacturing practice (GMP) requirements. PhRMA said it is “generally supportive” of the list developed by the agency as part of its obligations under the 21 st Century Cures Act and appreciates FDA’s commitment to str...
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    Support Mounts for FDA to Waive Bridging Studies for Biosimilars

    As part of FDA’s action plan on biosimilars, Commissioner Scott Gottlieb said in July the agency is “actively exploring" whether "in some circumstances" FDA can "facilitate the increased use of non-U.S.-licensed comparator products in certain studies to support" biosimilar applications.   The change would allow biosimilar developers to purchase reference product to demonstrate biosimilarity from Europe or other region without further demonstrating that the EU-licensed ...
  • FDA Disputes Breast Implant Study

    The US Food and Drug Administration (FDA) is raising concerns with a recent study’s methodologic and bias issues, with the director of FDA’s Division of Surgical Devices raising the concerns. The latest issue of Annals of Surgery includes a report on the long-term outcomes of 100,000 patients with breast implants in FDA-mandated post-approval studies that FDA previously assessed.  “Unfortunately, as the authors acknowledge, they failed to account for methodologic d...