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TXT House Committee Hearing on Drug Supply Chain Security [514 Words] [ Price : $7.95]
The House Energy and Commerce health subcommittee plans a hearing 4/25 on “Securing Our Nation’s Prescription Drug Supply.”
04/19/2013
 
 
TXT FDA Clears a MedShape 510(k) for Tissue Anchor [89 Words] [ Price : $7.95]
FDA clears a MedShape 510(k) for its Eclipse Soft Tissue Anchor, a shape memory fixation device designed to attach a tendon, ligament or soft tissue to bone.
04/19/2013
 
 
TXT Another Generic Failure-to-Warn Claim Dismissed [142 Words] [ Price : $7.95]
A federal appeals court upholds a lower court ruling that failure-to-warn suits against generic drug makers are preempted by federal law.
04/19/2013
 
 
TXT FDA Alliance Urges $40 Million Increase in FY 2014 Budget [258 Words] [ Price : $7.95]
The Alliance for a Stronger FDA urges Congress to provide FDA with an additional $40 million ($2.60 billion total) in budget authority for FY 2014 request.
04/19/2013
 
 
TXT Takeda Adds to Petition on Tighter Bio for Dexilant ANDAs [251 Words] [ Price : $7.95]
Takeda Pharmaceuticals supplements a citizen petition submitted earlier this year seeking to block ANDA approval for would-be generic Dexilant (dexlansoprazole) products due to bioequivalence concerns.
04/19/2013
 
 
TXT Consumers Union Urges FDA to Up-regulate Implantable Devices [286 Words] [ Price : $7.95]
Consumers Union urges FDA to adopt a proposed rule requiring metal hip implants and other high-risk implantables to be reviewed through the PMA process.
04/19/2013
 
 
TXT FDA Clears Compact MRI System for Wrist [93 Words] [ Price : $7.95]
FDA clears Aspect Imgaging’s M2 compact MRI system for diagnostic imaging of the wrist.
04/19/2013
 
 
TXT FDA Proposes Standardized Symbols on Device/Biologic Labeling [122 Words] [ Price : $7.95]
Federal Register Proposed rule: FDA proposes to revise medical device and biologic product labeling to allow for stand-alone standardized graphical symbols.
04/19/2013
 
 
TXT Info on CLIA Waivers Sent to OMB [46 Words] [ Price : $7.95]
Federal Register Notice: FDA sends a proposed collection of information on clinical laboratory improvement amendments waiver applications to the Office of Management and Budget.
04/19/2013
 
 
TXT OMB OKs Info on e-Submission of Device Registration [44 Words] [ Price : $7.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on the electronic submission of device registration and listing.
04/19/2013
 
 
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