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Merck/Pfizer Avelumab Flunks Gastric Cancer Trial

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Merck KGaA and Pfizer report that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall s...

Regulatory Review Period Determined for Veltassa

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Relypsas Veltassa (patirome...

Webinar Explains 510(k) Change Guidance

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An FDA webinar explains the principles underlying two new final guidances on when to submit a new 510(k) for changes to a medical ...

Dignity Health FDA-483 Released

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FDA releases the FDA-483 issued following an inspection at Northridge Hospital Dignity Health sterile drug products production fac...

IG Faults Drug Companies Caring Voice Charity

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The HHS Inspector General has withdrawn a favorable advisory opinion for the Caring Voice Coalition funded by drug companies to he...

Guide on CLIA Waivers for IVD Devices

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory ...

Rep. Slaughter Urges More FDA Antibiotic Resistance Efforts

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Rep. Louise Slaughter (D-NY) urges FDA to take stronger action to preserve the effectiveness of antibiotics and protect public hea...

Fully Implement, Enforce Compounding Law: Pew

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Pew Charitable Trusts public health director Elizabeth Jungman says progress has been made under the Drug Quality and Security Act...

Comprehensive Approach to Nicotine and Tobacco

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FDA officials announce a new committee to consider changes to reviewing and approving nicotine replacement therapy products.

Mixed Decision in a Preemption Case

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Attorney Michelle Yeary says a Tennessee federal court dismissed many parts of a failure-to-warn case against Boehringer Ingelheim...