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TXT QS and MDR Violations Found at Corpak [227 Words] [ Price : $7.95]
FDA’s Chicago District Office warns Corpak MedSystems about Quality System and Medical Device Reporting regulation violations in its manufacturing of disposable medical devices.
04/23/2013
 
 
TXT Regan-Udall Foundation Plans Annual Meeting [108 Words] [ Price : $7.95]
Federal Register Notice: The Regan-Udall Foundation for FDA plans its annual public meeting 5/23.
04/23/2013
 
 
TXT Latest FDA Warning Letters [825 Words] [ Price : $7.95]
In its latest batch of Warning Letters, FDA cites Alveologic, Birkdale Medicinals, Corpak MedSystems, Excel Medical Products, KayPentax, Oy Ajat, Puget Sound Blood Center, Synticare, and Women’s Health Institute of Texas.
04/23/2013
 
 
TXT Nora Recalls Compounded Products [161 Words] [ Price : $7.95]
FDA says Nora Apothecary & Alternative Therapies is recalling sterile drug products it compounded and dispensed in five states.
04/23/2013
 
 
TXT Scope of Immunogenicity Guidance Should be Clarified: Janssen [285 Words] [ Price : $7.95]
Janssen and BIO suggest principles FDA should consider in setting immunogenicity requirements for biosimilar testing.
04/23/2013
 
 
TXT Fraudulent FDA Inspectors Can Infiltrate Companies [312 Words] [ Price : $7.95]
Attorneys Lynn Tyler and Hae Park Suk say companies should be aware of the potential for impostors to present themselves for a fraudulent FDA inspection.
04/23/2013
 
 
TXT OMB OKs Info on Tobacco Constituents [56 Words] [ Price : $7.95]
Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on reporting harmful constituents in tobacco products.
04/23/2013
 
 
TXT Nominations Sought for Medical Evidence Committee [61 Words] [ Price : $7.95]
Federal Register Request: The Reagan-Udall Foundation for the FDA requests nominations for its Innovation in Medical Evidence Development and Surveillance Steering Committee.
04/23/2013
 
 
TXT Class 1 Recall for LifeScan’s OneTouch Blood Glucose Meter [174 Words] [ Price : $7.95]
FDA’s MedWatch program announces a Class 1 recall for LifeScan Inc.’s One Touch Verio IQ Blood Glucose Meter because it will fail to provide a warning at extremely high blood-glucose levels.
04/23/2013
 
 
TXT FDA, CytRx Reach Protocol Agreement on Sarcoma Therapy [536 Words] [ Price : $7.95]
FDA and CytRx reach an agreement on a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas.
04/23/2013
 
 
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