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CGMP Deviations at Zhejiang Huahai
[2724 Words]
[ Price : $8.95]
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| FDA warns China’s Zhejiang Huahai Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical ingredients. |
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12/11/2018
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Olympus Pays $85 Million for Failing to File Device Reports
[326 Words]
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| Olympus Medical Systems and a former senior executive plead guilty to failing to file required adverse event reports involving its duodenoscopes and associated infections; the company also pays $85 million for its actions. |
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12/11/2018
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India’s Skylark CMC Refuses FDA Inspection
[2717 Words]
[ Price : $8.95]
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| FDA warns India’s Skylark CMC over its refusal to permit agency inspectors to enter manufacturing areas and refusal to provide requested records. |
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12/11/2018
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FDA Meeting on Outsourcing Facilities’ Office Stock
[107 Words]
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| Federal Register notice: FDA announces a 5/21 public meeting entitled “FDA’s Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.” |
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12/11/2018
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Revised GMP Guide for Outsourcing Facilities
[102 Words]
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| Federal Register notice: FDA makes available a revised draft guidance entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” |
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12/11/2018
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4 New Biosimilar Guidances
[2932 Words]
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| FDA commissioner Scott Gottlieb outlines provisions in four guidances to help advance the agency’s Biosimilars Action Plan. |
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12/11/2018
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HHS Sued Over Trial Reporting Rule
[2940 Words]
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| Former FDAer Peter Lurie and journalism professor Charles Seife sue HHS, FDA, and NIH to overturn a final rule allowing some drug and medical device companies to avoid posting clinical trial results on ClinicalTrials.gov. |
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12/11/2018
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Biomarker Qualification Draft Guidance
[2678 Words]
[ Price : $8.95]
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| FDA issues a draft guidance on the evidentiary framework it recommends for biomarker qualification under the 21st Century Cures Act. |
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12/11/2018
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Amino Acid Polymer Product Assessment
[2729 Words]
[ Price : $8.95]
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| CDER issues a MAPP on procedures for integrated quality assessment of products containing drug substances composed of amino acid polymers. |
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12/11/2018
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Latest FDA Warning Letters
[218 Words]
[ Price : $8.95]
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| FDA releases its latest batch of Warning Letters that include Skylark CMC and Zhejiang Huahai Pharmaceutical. |
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12/11/2018
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