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Alpha Aesthetics Inspection QS, MDR Violations

[ Price : $8.95]

FDA warns Carson City, NV-based Alpha Aesthetics about Quality System and Medical Device Reporting violations in its manufacturing...

Remote Data Digital Health Guidance

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FDA issues a guidance with recommendations for remotely using digital health technologies in clinical investigations.

EUA Sought for Fluvoxamine as Covid Treatment

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University of Minnesota researchers ask FDA to approve an EUA for the generic antidepressant fluvoxamine as a Covid-19 treatment.

FDA Clinical Hold on Gilead HIV Trials

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FDA places a clinical hold on 10 Gilead trials of an investigational HIV drug.

Federal Register Notices 12/20-12/30

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FDA Webview posts the following Federal Register notices that published during our annual holiday break (12/20-12/30).

Global Medical Production Warning Letter

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FDA warns Chinas Global Medical Production about Quality System and Medical Device Reporting violations in its production of medic...

Impacta Hand Sanitizer Illegal: FDA

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FDA warns Chinas Guangzhou Shiruoni Cosmetics Co. about adulterated and misbranded Impacta hand sanitizer that was marketed in the...

Janssen Submits Teclistamab for Myleoma Indication

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Janssen asks FDA to approve its teclistamab for some multiple myeloma patients.

IMC Sanitizer Illegal: FDA

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FDA warns Chinas Guangdong Kemei Pharmaceutical Technology Co. it is marketing an unapproved, adulterated, and misbranded hand san...

Physiologic Closed-Loop Control Guidance

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FDA issues a draft guidance on technical considerations for medical devices with physiologic closed-loop control technology.