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FDA joins EU in seeking recall of certain Chinese-made valsartan products over potential cancer riskRecalls of certain drugs containing heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the U.S., as the FDA sought voluntary actions to take some affected drugs off the s2018/7/17
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FDA approves the first drug with an indication for treatment of smallpoxThe U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a conta2018/7/16
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FDA announces voluntary recall of several medicines containing valsartan following detection of an impurityThe U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high b2018/7/16
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FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactionsThe U.S. Food and Drug Administration today is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side eff2018/7/12
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Federal judge enters consent decree against Minnesota dairy farm for drug residue violationsU.S. District Judge Wilhelmina M. Wright for the District of Minnesota entered a consent decree of permanent injunction against Todd & Patty Meech Dairy Farm of Sebeka, Minn., and the farm’s own2018/7/12
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Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapiesOnce just a theory, gene therapies are now a therapeutic reality for some patients. These platforms may have the potential to treat and cure some of our most intractable and vexing diseases. The polic2018/7/12
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PHEXCOM audit Triveni pharmaceutical packaging materials (HDPE bottles) factory ended successfullyOn May 28, 2018,PHEXCOM audit expert Balaji conducted on-site audit of Triveni Polymers Pvt Ltd. 's pharmaceutical packaging plant in G.T.Road,Piao Maniyari kundli-131028,Distt Sonepat Haryana, India.2018/6/7
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PHEXCOM audit ACG pharmaceutical packaging materials (PVDC) factory concluded successfullyOn May 26, 2018,PHEXCOM audit expert Balaji conducted on-site audit on ACG Pharmapack Pvt Ltd. 's pharmaceutical packaging material factory in Shindewadi, India, Satara 412801,Maharashtra.The audited2018/6/4
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Federal judge enters consent decree against Minnesota dairy farm for drug residue violationsU.S. District Judge Wilhelmina M. Wright for the District of Minnesota entered a consent decree of permanent injunction against Todd & Patty Meech Dairy Farm of Sebeka, Minn., and the farm’s owner2018/7/11
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PRESS RELEASE: PHARMATECH & TRANSMED SYSTEMS ANNOUNCE STRATEGIC ALLIANCEPharmatech Inc., and TransMed Systems, Inc., Announce Strategic Alliance to Accelerate Oncology Clinical Research Enrollment Utilizing Real World Data Insights and Rapid Site Activation Methodol2018/7/11