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  • Regulatory NewsRegulatory News

    Device Supplier Settles Monopoly Allegations With FTC

    UK-based Invibio, the first company to sell implant-grade polyetheretherketone (known as PEEK) to the world’s largest medical device makers for spinal and other medical implants, has agreed to settle Federal Trade Commission (FTC) charges that it violated federal antitrust law by using long-term exclusive contracts to monopolize the PEEK market. According to the FTC, two other companies, Solvay Specialty Polymers (the US Food and Drug Administration [FDA] cleared the fir...
  • Feature ArticlesFeature Articles

    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • China: SFDA Issues New Draft Excipient Rules

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June to require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production. Under the draft guidelines, drug manufacturers will explicitly have the primary responsibility to assure the quality of the excipients that they obtain from their excipient suppliers. The goal of the draft rules is to "realize the full supervision of the...