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TXT FDA Grants Emergency Use Authorization for Quest Zika Test [127 Words] [ Price : $8.95]
FDA grants Quest Diagnostics an Emergency Use Authorization for the Zika Virus RNA Qualitative Real-Time RT-PCR test.
04/29/2016
 
 
TXT Tract Therapeutics Cell Therapy for Kidney Transplant Enters Phase 2 [167 Words] [ Price : $8.95]
FDA approves a Tract Therapeutics proposed Phase 2 trial to investigate the efficacy and safety of its novel cell therapy for kidney transplant recipients.
04/29/2016
 
 
TXT FDA Approves Teva NDA for Asthma Inhaler Expanded Use [119 Words] [ Price : $8.95]
FDA approves a Teva Pharmaceutical Industries supplemental NDA for ProAir RespiClick (albuterol sulfate) Inhalation Powder for treating or preventing bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for preventing exercise-induced bronchospasm.
04/29/2016
 
 
TXT FDA Consent Decree Against Franck Compounding Operations [364 Words] [ Price : $8.95]
A Florida federal judge enters a consent decree against Paul W. Franck of Ocala, FL that prohibits his drug compounding operations from making sterile drug products until they comply with GMPs.
04/29/2016
 
 
TXT CBER Releases eSubmitter Program for Vaccine AERS [101 Words] [ Price : $8.95]
Federal Register Notice: CBER releases a Vaccine Adverse Event Reporting System eSubmitter Program for the electronic submission of postmarketing individual case safety reports and attachments.
04/29/2016
 
 
TXT Comments Reopened on Liquid Chromatography-Spectrometry IVDs [50 Words] [ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on a public workshop on liquid chromatrography/mass-spectrometry-based in vitro diagnostic devices.
04/29/2016
 
 
TXT Patients Letter to GOP Rep. Chaffetz Urges Essure Probe [152 Words] [ Price : $8.95]
Patient group Essure Problems and Ennis & Ennis Law have written Congressman Jason Chaffetz (R-UT) urging a congressional investigation and hearing request over FDA’s approval of Bayer’s Essure contraceptive.
04/28/2016
 
 
TXT FDA Says Merck’s Cubicin Not Complying with PREA Study [2624 Words] [ Price : $8.95]
FDA says that Merck failed to meet its post-marketing pediatric trial deadline for Cubicin.
04/28/2016
 
 
TXT Eagle Asks Court to Force Bendeka Orphan Exclusivity [2945 Words] [ Price : $8.95]
Eagle Pharmaceuticals asks the DC federal court to order FDA to grant seven-year orphan drug exclusivity to its Bendeka.
04/28/2016
 
 
TXT FDA Suggests Biosimilars Review Model in BsUFA 2 [2626 Words] [ Price : $8.95]
FDA suggests that Biosimilars User Fee Act 2 contain review enhancements based on a model used under PDUFA.
04/28/2016
 
 
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