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TXT FDA Clears SeaSpine’s Anterior Cervical System [1136 Words] [ Price : $8.95]
FDA clears a SeaSpine Holdings 510(k) for its Shoreline ACS Anterior Cervical Standalone System, which features TruProfile technology.
10/27/2016
 
 
TXT Salix Wants Restrictions on Xifaxan ANDAs [2658 Words] [ Price : $8.95]
Salix asks FDA to require several specific test results for any ANDA citing any strength or indication of Xifaxan as the reference-listed drug.
10/27/2016
 
 
TXT GDUFA Regulatory Science Priorities [2722 Words] [ Price : $8.95]
FDA publishes generic drug regulatory science priorities for FY 2017.
10/27/2016
 
 
TXT FDA Awards Engility $112 Million Computational Science Contract [1149 Words] [ Price : $8.95]
FDA awards Engility Holdings a $112 million five-year contract for computational science and bioinformatics services.
10/27/2016
 
 
TXT SynCardia Driver System Problems Continue: FDA [2708 Words] [ Price : $8.95]
FDA says that new data indicate continuing increased mortality and neurological risks with use of SynCardia’s Temporary Total Artificial Heart Companion 2 Driver System.
10/26/2016
 
 
TXT Bio-IND MAPP Out [2658 Words] [ Price : $8.95]
The CDER Office of Generic Drugs issues a MAPP with policies and procedures for review of Bio-INDs.
10/26/2016
 
 
TXT Concerns Voiced on IRB Guidance [2718 Words] [ Price : $8.95]
Two stakeholders suggest improvements to an FDA/HHS guidance on written procedures for institutional review boards.
10/26/2016
 
 
TXT Changes Sought in 2 Compounding Guidances [2889 Words] [ Price : $8.95]
Four stakeholders raise concerns about and recommend changes to two draft guidances on drug compounding.
10/26/2016
 
 
TXT ISPE Wants Data Integrity Guidance Clarified [2627 Words] [ Price : $8.95]
The International Society for Pharmaceutical Engineering asks FDA for additional clarifications to a draft guidance on data integrity and complying with CGMP.
10/26/2016
 
 
TXT Comments Sought on IND Reporting Requirements Extension [1128 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on a submission to OMB seeking to extend an information collection related to “Format and Content Requirements for OTC Drug Product Labeling — 21 CFR Part 201.”
10/26/2016
 
 
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