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Theresa Mullin Retires as CDER Associate Director

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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...

FDA Expedited IND to Lean on Rolling Submissions/Reviews

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FDA officials detailing the agencys new expedited IND pilot program say a central feature will be a rolling pre-IND submission pro...

Lilly Files Six Lawsuits Over Illegal Retatrutide Sales

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Eli Lilly files six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products.

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 ...

3 Observations in MSN Life Sciences Inspection

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FDA releases the Form FDA-483 with three observations from a 2024 inspection at Indias MSN Life Sciences Unit II active pharmaceut...