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Welcome to FDAweb Pay Per View Search our 61,951 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers            1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   Draft Guide on Humanitarian Device Exemption Program [99 Words] [ Price : $8.95] FDA issues a draft guidance on its “Humanitarian Device Exemption (HDE) Program” that clarifies the current review practices for the regulatory pathway. 06/12/2018     Orphan Status for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     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     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     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     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     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     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     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     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       1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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