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TXT CGMP Deviations at Zhejiang Huahai [2724 Words] [ Price : $8.95]
FDA warns China’s Zhejiang Huahai Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical ingredients.
12/11/2018
 
 
TXT Olympus Pays $85 Million for Failing to File Device Reports [326 Words] [ Price : $8.95]
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.
12/11/2018
 
 
TXT India’s Skylark CMC Refuses FDA Inspection [2717 Words] [ Price : $8.95]
FDA warns India’s Skylark CMC over its refusal to permit agency inspectors to enter manufacturing areas and refusal to provide requested records.
12/11/2018
 
 
TXT FDA Meeting on Outsourcing Facilities’ Office Stock [107 Words] [ Price : $8.95]
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.”
12/11/2018
 
 
TXT Revised GMP Guide for Outsourcing Facilities [102 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.”
12/11/2018
 
 
TXT 4 New Biosimilar Guidances [2932 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb outlines provisions in four guidances to help advance the agency’s Biosimilars Action Plan.
12/11/2018
 
 
TXT HHS Sued Over Trial Reporting Rule [2940 Words] [ Price : $8.95]
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.
12/11/2018
 
 
TXT Biomarker Qualification Draft Guidance [2678 Words] [ Price : $8.95]
FDA issues a draft guidance on the evidentiary framework it recommends for biomarker qualification under the 21st Century Cures Act.
12/11/2018
 
 
TXT Amino Acid Polymer Product Assessment [2729 Words] [ Price : $8.95]
CDER issues a MAPP on procedures for integrated quality assessment of products containing drug substances composed of amino acid polymers.
12/11/2018
 
 
TXT Latest FDA Warning Letters [218 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that include Skylark CMC and Zhejiang Huahai Pharmaceutical.
12/11/2018
 
 
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