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Bipartisan Animal Testing Reform Bill

[ Price : $8.95]

Bipartisan members of the House introduce legislation to require FDA to produce a final rule to implement animal testing reforms a...

Breakthrough Designation for Back Pain Gel

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FDA grants Orthoson a breakthrough device designation for its Bio-Structural Gel and its use to reduce back pain caused by degener...

Amgen Seeks Expanded Blincyto Indication

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FDA accepts for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) for treating early-stage, CD19-positive B-ce...

Drug Manufacturing Discontinuance Guide

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FDA publishes a draft guidance with information on how applicants and manufacturers should inform the agency about discontinuance ...

Les Importations Herbasant CGMP Issues

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FDA warns Saint-Laurent, Canada-based Les Importations Herbasant about CGMP violations in its work as a contract drug manufacturer...

Think Like a Consumer on DTC Ads: Attorneys

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Three SheppardMullin attorneys say a recent Office of Prescription Drug Promotion untitled letter shows how FDA will continue to m...

CGMP Issues in Nantong Furuida Records Review

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FDA warns Chinas Nantong Furuida Packaging Products about a CGMP violation in its manufacturing of over-the-counter drugs.

Vanda sNDA Hetlioz Review Hits Snag: FDA

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FDA tells Vanda Pharmaceuticals that its ongoing review of a Hetlioz (tasimelteon) supplemental NDA has identified deficiencies th...

3 Ways Congress Can Cut Drug Shortages: Duke-Margolis

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The Duke-Margolis Institute for Health Policy makes three recommendations to the House Ways and Means Committee on policy solution...

FDA Skips Foreign Inspection Hearing

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FDA declines to appear before the House Energy and Commerce Oversight and Investigations Subcommittee as it holds a critical heari...