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TXT Draft Guide on Humanitarian Device Exemption Program [99 Words] [ Price : $8.95]
FDA issues a draft guidance on its “Humanitarian Device Exemption (HDE) Program” that clarifies the current review practices for the regulatory pathway.
06/12/2018
 
 
TXT Orphan Status for Chiesi Cell Therapy for Eye Condition [100 Words] [ Price : $8.95]
FDA grants Chiesi USA an orphan drug designation for GPLSCD01, ex-vivo expanded autologous human corneal epithelial cells containing stem cells, for treating limbal stem cell deficiency.
06/12/2018
 
 
TXT Safety Update on Certain Heater-Cooler Devices [109 Words] [ Price : $8.95]
FDA issues a safety update on LivaNova’s Stӧckert 3T Heater-Cooler System to help prevent the spread of infection related to the use of the devices.
06/12/2018
 
 
TXT 2 Updated Medical Product Communications Guidances [2846 Words] [ Price : $8.95]
FDA finalizes two guidances with recommendations on industry communications with payors and other entities.
06/12/2018
 
 
TXT Lilly, AstraZeneca Scrap Phase 3 Alzheimer’s Studies [112 Words] [ Price : $8.95]
Based on disappointing data, Eli Lilly and AstraZeneca are discontinue global Phase 3 clinical trials of lanabecestat for treating Alzheimer’s disease.
06/12/2018
 
 
TXT Taiwan Biotech CGMP Violations [2872 Words] [ Price : $8.95]
FDA warns Taiwan’s Taiwan Biotech about CGMP violations in its production of finished drugs.
06/12/2018
 
 
TXT Heart Trial Protocol Changed: Public Citizen [2888 Words] [ Price : $8.95]
Public Citizen says HHS has made changes to an NIH cardiac trial protocol and consent form to ease ethical concerns raised by the advocacy group.
06/12/2018
 
 
TXT Latest FDA Warning Letters [133 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes one medical product company — Taiwan Biotech Company.
06/12/2018
 
 
TXT Court Orders Bendeka Orphan Status [2611 Words] [ Price : $8.95]
The DC federal court orders FDA to grant orphan drug exclusivity to Eagle Pharmaceuticals’ Bendeka.
06/12/2018
 
 
TXT Appeals Court Backs Lipitor Case Dismissal [2702 Words] [ Price : $8.95]
The 4th Circuit Court of Appeals upholds a lower court decision dismissing multi-state litigation alleging that patients contracted diabetes after taking Lipitor.
06/12/2018
 
 
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