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TXT FDA OKs R-Tech Ueno IND Severe Dry Eye Treatment [75 Words] [ Price : $7.95]
FDA approves an IND application from R-Tech Ueno for Phase 1/2 trials of its RU-101 ophthalmic solution for treating dry eye.
04/26/2013
 
 
TXT Hospira Recalls 1 Lot of Sodium Chloride [95 Words] [ Price : $7.95]
Hospira recalls one lot of 0.9% sodium chloride injection, USP, 100 mL, flexible container after confirming a customer complaint involving particulate issues.
04/26/2013
 
 
TXT Appeals Court Rules for Preemption in Generic Reglan Case [249 Words] [ Price : $7.95]
Citing federal preemption grounds, an Iowa appeals court affirms several lower court decisions dismissing a failure-to-warn lawsuit by an injured plaintiff taking generic Reglan.
04/26/2013
 
 
TXT FDA Warns on Bogus Botox [212 Words] [ Price : $7.95]
An FDA drug safety alert warns about fraudulent versions of Allergan’s Botox being sold to U.S. medical practices.
04/26/2013
 
 
TXT FDA Class 1 Recall for Infant Masks [94 Words] [ Price : $7.95]
FDA classifies as Class 1 an Engineered Medical Systems recall of its SealFlex Single Port Ribbed Mask (Infant) due to mislabeling.
04/26/2013
 
 
TXT Guidance on Pharmaceutical Co-Crystals [108 Words] [ Price : $7.95]
Federal Register Notice: FDA releases a guidance, Regulatory Classification of Pharmaceutical Co-Crystals.
04/26/2013
 
 
TXT Amphastar Whistleblower Complaint Against Aventis Moves On [323 Words] [ Price : $7.95]
A California federal court says Amphastar’s whistleblower suit against Aventis alleging fraudulent Medicare and Medicaid claims for Lovenox may continue.
04/25/2013
 
 
TXT Woodcock Urges Congress to Move Forward on Track-and-Trace [783 Words] [ Price : $7.95]
CDER director Janet Woodcock urges Congress to come to terms on legislation to implement an effective national track-and-trace system for all drug products throughout the supply chain.
04/25/2013
 
 
TXT Guidance on Assay Migration Studies for IVDs [84 Words] [ Price : $7.95]
Federal Register Notice: FDA releases a guidance: Assay Migration Studies for In Vitro Diagnostic Devices.
04/25/2013
 
 
TXT Actavis, Shire Reach Agreement on Generic Intuniv for ADHD [93 Words] [ Price : $7.95]
Actavis Inc. and Shire reach an agreement to resolve patent litigation for Actavis’ generic version of Shire’s ADHD drug Intuniv.
04/25/2013
 
 
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