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FDA to Make Compounding Difficulty Lists

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FDA proposes to evaluate drugs and categories of drugs that present demonstrable difficulties for compounding and place three cate...

Bipartisan Bill to Shore Up Emergency APIs

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Two U.S. House lawmakers introduce a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) use...

FDA Withdraws NDA/NADA for Helium

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Federal Register notice: FDA withdraws approval of an Air Products and Chemicals NDA and new animal drug application for medical g...

Renal PK Study Guidance

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FDA publishes a guidance to assist in the design and analysis of studies assessing the influence of impaired renal function on an ...

Iclusig Accelerated Approval for Leukemia

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FDA grants Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with new...

FDA Accepts BLA Resubmission for Lymphir

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FDA accepts for review a Citius Pharmaceuticals BLA resubmission for Lymphir (denileukin diftitox), an interleukin-2-based immunot...

Senators Want Defense Drug Supply Security Update

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A bipartisan group of nine senators asks the Defense Department for an update on its efforts to secure the military pharmaceutical...

Changes Proposed to Manufacturing Tech Draft

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Two stakeholders make suggestions to revise an FDA draft guidance on its new drug advanced manufacturing technology designation pr...

FDA Warning Letters on Chinese Syringes

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FDA sends Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline In...

FDA OKs Chronic Rhinosinusitis Nasal Spray

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FDA approves an Optinose NDA for Xhance (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal pol...