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Input Sought on FDA Minority Health Priorities

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Federal Register notice: FDA seeks input and comments from interested stakeholders to help it establish strategic priorities for i...

Aurobindo Recalls Mirtazapine Over Label Error

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Aurobindo Pharma recalls one lot of mirtazapine due to a label error on declared strength.

Non-Clinical Bench Performance Guidance Out

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FDA issues a guidance describing relevant information to be included in premarket submissions reporting non-clinical bench perform...

FDA Vaping Enforcement Priorities Guidance

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FDA publishes a guidance on its enforcement priorities for Electronic Nicotine Delivery System (vaping) products being marketed wi...

Neovasc PMA Filed for Refractory Angina Device

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Neovasc files a PMA for its Neovasc Reducer for treating refractory angina.

Some Drug Companies Raise Prices for 2020

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Several drug companies raise prices on some 250 drugs for 2020.

Mesoblast Rolling BLA Submission for Remestemcel-L

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Mesoblast files as part of a rolling BLA clinical efficacy and safety data for remestemcel-L, indicated for treating children with...

FDA Drops Peptide Transition Exclusion

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FDA says that allowing chemically synthesized peptides to use the biosimilar or interchangeable approval pathway will benefit cons...

Amarin Gains Expanded Use for Vascepa

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FDA approves the expanded use of Amarins Vascepas (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to s...

De Novo Authorization for Glycemic Controller

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FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controlle...