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TXT Labeling Changes Approved for 48 Drug Products in April [352 Words] [ Price : $7.95]
FDA releases labeling changes approved for 48 drugs in April, including a new Boxed Warning for Boehringer Ingelheim’s Pradaxa
05/16/2013
 
 
TXT Concerns Raised on Product Design Draft Guidance [267 Words] [ Price : $7.95]
Concerns are raised by several stakeholders about FDA’s draft guidance on product design to minimize medication errors.
05/16/2013
 
 
TXT FDA Clears New Biolase X-ray System [113 Words] [ Price : $7.95]
FDA clears a Biolase 510(k) for the NewTom Biolase VG3 digital panoramic, cephalometric, and tomographic extra-oral X-ray system.
05/16/2013
 
 
TXT 2 Drug Safety Signals Identified in First Quarter [76 Words] [ Price : $7.95]
FDA says it identified potential safety signals for two products in the first quarter of 2013.
05/16/2013
 
 
TXT AdvaMed Has Concerns About Infusion Pump Guidance [205 Words] [ Price : $7.95]
AdvaMed says an infusion pump assurance case template developed by an industry working group can better provide assurance case information to FDA.
05/16/2013
 
 
TXT Anaphylaxis Awareness Promoted by Bettis, Sanofi-Aventis [205 Words] [ Price : $7.95]
Sanofi-Aventis and former pro football star Jerome Bettis promote analphylaxis awareness and the company’s Auvi-Q.
05/16/2013
 
 
TXT Improvements Sought in Draft Diagnostic Device Guidance [285 Words] [ Price : $7.95]
AdvaMedDx and Microbiologics suggest ways FDA can improve a draft guidance on multiplexed microbiological/medical countermeasures in vitro nucleic acid based diagnostic devices.
05/16/2013
 
 
TXT Comments Sought on Ruminant Feed Recordkeeping [51 Words] [ Price : $7.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on recordkeeping requirements on animal proteins prohibited in ruminant feed.
05/16/2013
 
 
TXT 2 New and 8 Updated Medication Guides Out [68 Words] [ Price : $7.95]
FDA says new Medication Guides have been issued for two drugs and updated guides for eight other drugs.
05/16/2013
 
 
TXT Public Citizen Criticizes HELP Committee Compounding Bill [226 Words] [ Price : $7.95]
Public Citizen says a Senate bill to regulate drug compounding by creating a new entity called compounding manufacturers would be a step backward for drug safety.
05/16/2013
 
 
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