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NMPA Issued the Guidelines for Adverse Event Classification Standards for Clinical Trials of Preventive Vaccines
2019-12-31
NMPA has organized the drafting of and released on December 31, 2019 the Guidelines for Adverse Event Classification Standards for Clinical Trials of Preventive Vaccines.
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NMPA Issued the Announcement on the Guidelines for Real-World Evidence to Support Drug Development and Review (Interim)
2020-01-07
NMPA has organized the formulation of the Guidelines for Real-World Evidence to Support Drug Development and Review (Interim).
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NMPA Issued the Guidelines for Clinical Trials of Drugs for Treatment of Nonalcoholic Steatohepatitis (Interim)
2019-12-20
NMPA has organized the formulation of the Guidelines for Clinical Trials of Drugs for Treatment of Nonalcoholic Steatohepatitis (Interim), which was released on December 20, 2019.
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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.