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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The HHS Inspector General has withdrawn a favorable advisory opinion for the Caring Voice Coalition funded by drug companies to he...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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory ...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...

Dual 510(k) CLIA Waiver Guidance

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FDA issues a draft guidance leveraging its experience in implementing the MDUFA 3 Dual 5120(k) and CLIA Waiver by Application path...

CGMP Violations at Koreas Dae Young Foods

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FDA warns South Koreas Dae Young Foods Company about CGMP and misbranding violations in its work as a contractor manufacturing fin...

Sentinel Role in Drug Safety Defended

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CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the ways in which the agencys Sentinel System i...

FDA Has Most of HHS Withdrawn Regulations: Survey

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A Public Citizen analysis of 457 rulemakings withdrawn by the Trump administration finds that 26 were from FDA, the highest number...