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TXT Quality System Violations at Italy’s Interlab [263 Words] [ Price : $7.95]
FDA warns Italy’s Interlab about Quality System violations in its manufacturing of test kits.
05/15/2013
 
 
TXT Inspection Finds QS Problems at Electromedical Products [213 Words] [ Price : $7.95]
FDA’s Dallas District Office warns Electromedical Products International about Quality System Regulation and other violations in its manufacturing of a microcurrent and cranial stimulator.
05/15/2013
 
 
TXT Norbrook Opposes Bayer Baytril Petition [251 Words] [ Price : $7.95]
Norbrook Laboratories and Bayer Animal Health submit opposing petitions to FDA on whether generic Baytril 100 should be approved.
05/15/2013
 
 
TXT Latest FDA Warning Letters [962 Words] [ Price : $7.95]
In it latest batch of Warning Letters, FDA cites Desert Rose Manufacturing, Electromedical Products, Entrenet Nutritionals, Interlab, Juve International, Rubimed, Shippert Medical Technologies, SmartPractice Denmark, and Weber Medical.
05/15/2013
 
 
TXT FDA Gets ‘Extraordinary’ Response to Human Factors Guidance [1744 Words] [ Price : $7.95]
FDA human factors specialist QuynhNhu Nguyen describes as “extraordinary” the number of comments the agency has received on its 2011 draft guidance, and gives other insights on the issue.
05/15/2013
 
 
TXT FDA Approves Mylan’s Generic Zomig [115 Words] [ Price : $7.95]
FDA approves a Mylan ANDA for a generic copy of IPR Pharmaceuticals’ migraine drug Zomig.
05/15/2013
 
 
TXT FDA Clears DiFusion’s Spinal Implant Raw Material [98 Words] [ Price : $7.95]
FDA clears a DiFusion Technologies 510(k) for Xiphos Alif LIF, a Vestakeep PEEK-based (polyetheretherketone) spinal implant material.
05/15/2013
 
 
TXT House Committee Passes Legislation on Drug Supply Chain [527 Words] [ Price : $7.95]
The House Committee on Energy and Commerce votes to advance legislation to the House floor on securing the U.S. prescription drug supply chain and reauthorize two important drug user fee programs for new and generic animal drugs.
05/15/2013
 
 
TXT Consider Both Social Media Benefits and Risks: Study [290 Words] [ Price : $7.95]
Researchers say FDA should move quickly give companies guidance on using social media in healthcare communications.
05/15/2013
 
 
TXT Senators Introduce Compounding Bill [248 Words] [ Price : $7.95]
Senate HELP Committee members introduce legislation to clarify oversight responsibility over compounding manufacturers.
05/15/2013
 
 
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