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BIO Comments on Opioid Use Disorder Guidance

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Biotechnology Innovation Organization submits comments to FDA on its draft guidance Opioid Use Disorder (OUD): Endpoints for Demon...

Vapotherm Ventilator Cleared for Expanded Use

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FDA clears a Vapotherm 510(k) for its latest version of its Precision Flow Hi-VNI system, which includes a new product category an...

Comments Sought on WHO Drug Scheduling for 16 Drugs

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Federal Register notice: FDA requests comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impa...

Feds Back Merck in Fosamax Warning Case

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A federal government brief tells the Supreme Court that the 3rd Circuit Court of Appeals erred in reversing a lower court decision...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Becton Dickinson.

QS Violations at BD Manufacturing Facility

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FDA warns Becton Dickinson about Quality System issues at one of its manufacturing facilities.

New TDS Generic Drug Development Guidances

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FDA issues guidances to promote development of generic transdermal and topical delivery systems.

Qualigen 510(k) for FastPack IP Sex Hormone Assay

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Qualigen has submitted a 510(k) for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay, indicated for the quantitativ...

Reviewers See Oliceridine Abuse, Overdose Potential

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FDA medical reviewers tell members of the Anesthetic and Analgesic Drug Products Advisory Committee that they believe Trevenas oli...

ECAN OTC Heartburn Drug Petition Denied

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FDA denies a petition asking for a warning about the risk of esophageal cancer on labels for OTC heartburn products.