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TXT FDA International Drug GMP Actions Up 60% [701 Words] [ Price : $7.95]
FDA says international GMP actions have grown by about 60% since 2008.
04/16/2013
 
 
TXT Petition to Block Release of Warning Letter Withdrawn [339 Words] [ Price : $7.95]
Hyman, Phelps & McNamara withdraws a petition to FDA that sought to delay the posting of an unnamed client’s Warning Letter until an appeal had been exhausted and requested redactions were made.
04/16/2013
 
 
TXT FDA Sets Generic Drug Facility Reporting Dates [70 Words] [ Price : $7.95]
Federal Register Notice: FDA announces the dates for generic drug facility self-identification reporting for fiscal year 2014.
04/16/2013
 
 
TXT FDA Releases Electronic Format Support Document [46 Words] [ Price : $7.95]
Federal Register Notice: FDA releases the document, “Specifications for File Format Types Using eCTD Specification,” to support electronic format regulatory submissions.
04/16/2013
 
 
TXT Latest FDA Warning Letters [348 Words] [ Price : $7.95]
In its latest batch of Warning Letters, FDA cites Baxter Healthcare, ForMor, and Kanebo Cosmetics.
04/16/2013
 
 
TXT Public Citizen Wants Cardiac Compressor Reclassification Pulled [306 Words] [ Price : $7.95]
Public Citizen asks FDA to withdraw its proposal to reclassify automated external cardiac compression devices, while Laerdal Medical voices support for the change.
04/16/2013
 
 
TXT Hamburg Takes Heat in Hearing on Pharmacy Compounding [884 Words] [ Price : $7.95]
FDA commissioner Margaret Hamburg takes significant criticism from House Republicans during a hearing on pharmacy drug compounding.
04/16/2013
 
 
TXT FDA Faulted for Leaving Suspect Drugs on Market [712 Words] [ Price : $7.95]
A detailed ProPublica report criticizes FDA’s handling of five years of falsified drug tests by Cetero Research.
04/16/2013
 
 
TXT FDA Clears Carticept Musculoskeletal Injection System [122 Words] [ Price : $7.95]
FDA clears a Carticept Medical 510(k) for the Navigator Delivery System (DS), a computer-controlled injection system for musculoskeletal injections.
04/15/2013
 
 
TXT Abbott Recalls FreeStyle InsuLinx Meters [261 Words] [ Price : $7.95]
Abbott recalls its FreeStyle InsuLinx Blood Glucose Meters due to potential blood glucose display errors when extremely high blood glucose test results are measured.
04/15/2013
 
 
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