ASTM Publishes Standards For Implantable Device Polymer
The American Society for Testing and Materials last week released a new international standard on the use of certain plastics in implantable devices. The document is intended for use by resin makers who sell their products to devicemakers, as well as by device manufacturers and regulators. ASTM F2820 applies to virgin polyetherketoneketone (PEKK) polymer resin supplied in the form of pellets, powder or fabricated forms. . . .
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Tougher USP Heparin Standard No Substitute for Stringent Supplier Controls, FDA Says
While an impending update to the U.S. Pharmacopeia's (USP) reference standard for heparin sodium will sharpen the drug's monograph, there is no substitute for solid supplier quality control to prevent contaminants in heparin and other active pharmaceutical ingredients (API), FDA officials say. The revised monograph that USP will propose in November looks strong, but it's unlikely it will actually help manufacturers and API purchasers detect all contaminants in heparin, Ali Al-Hakim, a branch chief at CDER's Office of New Drug Quality Assessment and USP's heparin expert, said at an August heparin workshop in Rockville, Md. hosted by USP. USP scientist Anita Szajek agreed, saying the compendium's monographs would run a mile long if they included methods for detecting every kind of contaminant. The organization did update its heparin sodium standard in 2009 with a more potent assay method for detecting over-sulfated chondroitin sulfate (OSCS) in response to the 2008 heparin crisis. . . .
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Three Years’ Grace Sought on SEC Conflict Mineral Rule
The Securities and Exchange Commission (SEC) should allow a three-year grace period for devicemakers and other U.S. companies to comply with a mandate that companies disclose use of “conflict minerals” mined in Central Africa, AdvaMed says. . . .
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