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1st OTC Continuous Glucose Monitor Cleared

[ Price : $8.95]

FDA clears a Dexcom 510(k) for the companys Stelo Glucose Biosensor System, which the agency says is the first over-the-counter co...

Info Collection on FDA Drug Communications

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Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications...

Bell Intrnatl. Labs Warned Over CGMP Violations

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FDA warns Eagan, MN-based Bell International Laboratories about CGMP violations in its production of finished drugs.

CGMP Violations Found at Colgin

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FDA warns Dallas, TX-based Colgin, Inc., about CGMP violations in its production of finished drugs.

QS, MDR Violations at Fresenius Kabi Facility

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FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Iven...

New Dietary Ingredient Notification Guidance

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FDA publishes a guidance on the procedures and timeframes for submitting a required New Dietary Ingredient Notification.

Comments on FDA Guidance Best Practices

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Four stakeholders respond to an FDA request for comment on guidance best practices.

Follow Laws Intent on Drug Innovation: Scott, Carter

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Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match cong...

Genetic Metabolic Diseases Panel Established

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Federal Register notice: FDA amends its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic...

Zevra Therapeutics NDA Review Extended

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FDA extends by three months its review on a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment...