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Gore and Tongren voluntarily recall hydrophilic coated guiding sheath
2019-12-19
Due to labeling mistakes, the manufacturers Gore Industrial Products Trade (Shanghai) Co., Ltd and Tongren Co., Ltd initiated the voluntary recall of specific batches of hydrophilic coated guiding sheath.
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Howmedica Osteonics Corp. voluntarily recalls hip joint prosthesis-polyethylene lining
2019-12-19
Due to the lack of locking metal wire on particular batches of hip joint prosthesis-polyethylene lining, the manufacturer Howmedica Osteonics Corp. initiated the voluntary recall of the product. The recall is identified as a Class III recall.
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Siemens Healthcare Diagnostics Inc. voluntarily recalls High Sensitivity C Reactive Protein Calibrator (hsCRP CAL)
2019-12-19
Due to discrepancy in the testing results of particular batches of High Sensitivity C Reactive Protein Calibrator (hsCRP CAL) which cannot be identified in quality control, the manufacturer initiated the voluntary recall of the product.
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NMPA issues announcement on the adoption of 13 ICH safety guidelines (NMPA Announcement No. 89 [2019])
2019-12-19
To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 13 ICH safety guidelines, including S1A: Need for Carcinogenicity Studies of Pharmaceuticals.
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NMPA announces adoption of 15 ICH efficacy guidelines (NMPA Announcement No. 88 [2019])
2019-12-19
To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 15 ICH efficacy guidelines, including E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening Conditions.
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NMPA Promulgated the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor VIII and the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor IX
2019-07-18
NMPA organized the formulation of the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor VIII and the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor IX, which were issued on June 11, 2019.
