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FDA Warns of Accidental Benzonatate Ingestion

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FDA warns that accidentally ingesting branded and generic forms of benzonatate by children under age 10 can lead to overdose and d...

Lilly Investigational Melanoma Drug on Clinical Hold

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Eli Lilly suspends for safety reasons a global Phase 3 study evaluating tasisulam, an investigational, anti-cancer compound for us...

Review Period Set for Freestyle Navigator

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Federal Register Notice: FDA determines the regulatory review period for Abbotts Freestyle Navigator for the purpose of patent ext...

Samsca Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Otsuka Pharmaceuticals Samsca.

Vibativ Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Theravance Inc.s Vibativ for the purpose of patent extens...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites BioCheck Inc. Eagle Health Supplies, Hill Dermaceuticals, and Soma Labs.

New FDA Guidance on Co-developed Combination Drugs

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A new FDA guidance provides the agency's current thinking for sponsors intending to develop a combination product involving two or...

FDA, Industry Differ on Non-binding Advice Process

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FDA says an industry PDUFA 5 proposal for brief teleconferences to clarify issues for emerging drug development programs would be ...

High Court to Decide Generic Drug Preemption

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The U.S. Supreme Court agrees to hear consolidated appeals involving generic drug preemption.

FDA Clears Chest Tube Clearing System

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FDA clears a Clear Catheter Systems 510(k) for its innovative PleuraFlow Active Tube Clearance System.