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TXT CDRH Asked to Consider Hill-Rom Bed Flaw [2712 Words] [ Price : $8.95]
CDRH is looking into the potential for biohazard accumulation in alcove joints of Hill-Rom Total Care beds used in many hospital ICUs.
11/02/2016
 
 
TXT Celgene, IBM Watson Partner on New Pharmacovigilance Program [1312 Words] [ Price : $8.95]
Celgene and IBM Watson Health collaborate to co-develop IBM Watson for Patient Safety, a new program that aims to enhance pharmacovigilance methods used to collect, assess, monitor, and report adverse drug reactions.
11/02/2016
 
 
TXT FDA Workshop Planned for Generic Drug Research [1121 Words] [ Price : $8.95]
FDA says it will be holding a public workshop 5/3/2017 to obtain input from industry and other interested stakeholders on the identification of generic drug regulatory science priorities for FY 2018.
11/02/2016
 
 
TXT Lap-Band Post Approval Study Completed [1194 Words] [ Price : $8.95]
Apollo Endosurgery says it has completed a post-approval study of its Lap-Band AP Adjustable Gastric Band called HERO (Helping Evaluate Reduction in Obesity).
11/02/2016
 
 
TXT Sterile Drug Deficiencies at Option Care (Walgreens) [2781 Words] [ Price : $8.95]
FDA’s Dallas District Office warns Option Care Enterprises (formerly Walgreens Home Care) about aseptic processing operation violations in its production of sterile drugs.
11/01/2016
 
 
TXT Comments Sought on Patent Term Revision Petition Extension [1119 Words] [ Price : $8.95]
Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection on “Patent Term Restoration Due Diligence Petitions.”
11/01/2016
 
 
TXT Comments Sought on IRB Recordkeeping Requirements Extension [1086 Words] [ Price : $8.95]
Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend the recordkeeping requirements for institutional review boards.
11/01/2016
 
 
TXT FDA Extends Comment Period on MDUFA Reauthorization [1095 Words] [ Price : $8.95]
Federal Register Notice: FDA extends the comment period for the Medical Device User Fee Amendments reauthorization draft recommendations that were announced in a 10/7 notice.
11/01/2016
 
 
TXT Pfizer Scraps Cholesterol Drug on Disappointing Study Results [1351 Words] [ Price : $8.95]
Pfizer says it will discontinue its global clinical development program for bococizumab, an investigational proprotein convertase subtilisin kexin type 9 inhibitor intended for treating high cholesterol.
11/01/2016
 
 
TXT Califf: Base Clinical Trials on Data Sources [2701 Words] [ Price : $8.95]
FDA commissioner Robert Califf says that data sharing will be the next big scientific revolution.
11/01/2016
 
 
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