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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Deb USA and 21st Century Scientific.

Gottlieb Joins Aetions Board of Directors

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Former FDA commissioner Scott Gottlieb joins Aetions board of directors.

New FDA KASA System Explained

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Six CDER staffers explain the new FDA Knowledge-aided Assessment & Structured Application system being developed and implemented t...

Takeda Recalls Natpara Over Rubber Particulates

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Takeda Pharmaceutical Co. recalls all doses of Natpara (parathyroid hormone) for injection due to a potential issue related to rub...

Panel on Cybersecurity Communications Standards

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An FDA advisory committee recommends that FDA should develop standards for device companies to use when any cybersecurity concern ...

53 Product-Specific Guidances for ANDAs

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Federal Register notice: FDA makes available 53 product-specific guidances (PSGs) 34 new guidances and 19 revised ones.

3 Clinical Outcome Assessment Grants Awarded

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FDA awards three grants under a pilot program to support developing publicly available clinical outcome assessments and related en...

FDA Revokes Zika Test Emergency Authorization

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Federal Register notice: FDA revokes an Emergency Use Authorization issued to Siemens Healthcare Diagnostics for the Advia Centaur...

Abernathy Promotes Modern IT for Product Review

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FDA principal deputy commissioner Amy Abernathy says the agency will announce within a month a plan to modernize its information t...

Janssen Files Tremfya sBLA for Psoriatic Arthritis

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Janssen Pharmaceutical files a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthrit...