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Renal PK Study Guidance

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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Two stakeholders make suggestions to revise an FDA draft guidance on its new drug advanced manufacturing technology designation pr...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

FDA Cites GMPs in Abeona Inspection

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FDA issues a Form 483 after it finishes a pre-license inspection of Abeonas Cleveland, OH manufacturing facility concerning the co...

Guide on Animal Drug Mfg. Batches

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FDA releases a draft guidance entitled Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.

Date Correction in Alzheimers Guidance

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Federal Register notice: FDA corrects a date in a 3/12 notice announcing the availability of a guidance entitled Early Alzheimers ...