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Ban Infants Tylenol: Childrens Health Defense

[ Price : $8.95]

Childrens Health Defense petitions FDA to ban Infants Tylenol and place Boxed Warnings on labeling for some other Tylenol products...

Use More Advisory Committee Temporary Voting Members: Column

[ Price : $8.95]

A Center for Medicine in the Public Interest opinion column calls on FDA to more aggressively recruit and use advisory committee t...

FDA Obstacles Lead to Overseas Trials: Survey

[ Price : $8.95]

A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas.

Theresa Mullin Retires as CDER Associate Director

[ Price : $8.95]

CDER associate Center director for strategic initiatives Theresa Mullin retires after 28 years at the agency.

FDA Guide Updates Procedures for Formal Drug/Biologic Meetings

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FDA posts an updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or...

Hamilton Medical Removes Breathing Circuit Set

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An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMIL...

Belite Bio Files NDA for Stargardt Disease

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FDA accepts for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1.

New Pathway Sought for Albuterol Inhalation Aerosol Products

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A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers.

Veloxis Paying $46 Million to Resolve Kickback Charges

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The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company i...

Aquestive Will Resubmit Anophylm NDA in 3rd Quarter

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Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete ...