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ICH Viral Safety Evaluation Guidance

[ Price : $8.95]

FDA publishes an ICH guidance on evaluating the viral safety of biotechnology products derived from human or animal cell lines.

No Clarity Yet on Ozempic Suicide Risk: FDA

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FDA says it has not been able to establish a causal connection between suicidal ideation and drugs like Ozempic and Wegovy and is ...

Stakeholders Take Shots at FDA SIUU Communication Guide

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Four major stakeholder groups air their disagreement with an FDA revised draft guidance on firms communicating scientific informat...

Zeta Surgical Cranial Navigation Device Cleared

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FDA clears a Zeta Surgical 510(k) for its Zeta Cranial Navigation System.

Busse Hospital Recalls Tracheostomy Tray Kits

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Busse Hospital Disposables recalls its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurs...

Draft Guide on ANDA Reconsideration

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Federal Register notice: FDA makes available a draft guidance entitled Requests for Reconsideration at the Division Level Under GD...

Info Collection on E-Records/E-Signatures

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Federal Register notice: FDA sends to OMB an information collection revision entitled Electronic Records; Electronic Signatures 2...

CGMP Violations at Woorilife & Health

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FDA warns South Koreas Woorilife & Health about CGMP violations in its manufacturing of over-the-counter drugs.

MDR Violations at Neitz Instruments

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FDA warns Ichibancho, Japan-based Neitz Instruments Company about Medical Device Reporting violations in its manufacturing of its ...

Objectionable Conditions in Childrens Hospital Trials

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FDA warns Dr. Jeffrey Taub and the Childrens Hospital of Michigan about objectionable conditions in two clinical investigations.