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OHM Inspection Finds CGMP Issues

[ Price : $8.95]

FDA warns OHM Pharma about CGMP and other violations in its manufacturing of finished pharmaceuticals.

OrthoGrid Systems PhantomMSK Trauma Cleared

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FDA clears an OrthoGrid Systems 510(k) for its application PhantomMSK Trauma for use in orthopedic surgery.

Advance Notice, Staffing Still Harm Foreign Inspections: GAO

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New Government Accountability Office findings on FDAs foreign inspection program acknowledge improvements pointing up persistent r...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes OHM Pharma and Teligent Pharma.

Impurity Concerns Spread to Metformin Generics

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FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and r...

Magnetic Resonance Coil Performance Criteria Guide

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Federal Register notice: FDA releases a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Perfor...

House Bill Introduced to Lower Drug Costs

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Republican House lawmakers introduce the Lower Costs, More Cures Act (H.R. 19) to lower drug costs for Americans without limiting ...

Equillium Gets Fast Track for Itolizumab

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FDA grants Equillium a fast track designation for itolizumab for treating lupus nephritis.

Draft Guidance Hemorrhoid Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Development of Locally Applied Corticosteroid Products for ...

Smart Space Shoulder Arthroplasty Planner Cleared

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FDA clears a LimaCorporate and TechMah Medical 510(k) for the Smart Space Shoulder 3D Planner & 3D Positioner for shoulder arthrop...