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QS Violations at Ming Fai Industrial

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FDA warns Chinas Ming Fai Industrial Co about QS violations in its production of ultrasound gel and probe cover products.

Insanitary Conditions at Indias Global Pharma

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A lengthy FDA Warning Letter details issues at Indias Global Pharma Healthcare that led to contaminated ophthalmic drugs.

Bayer Withdrawing Aliqopa After Failed Study

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Bayer withdraws its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least t...

Nonprescription Panel Renewed for 2 Years

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Federal Register notice: FDA renews the Nonprescription Drugs Advisory Committee for an additional two years.

Former BD Exec Petitions FDA on Mesh Products

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Former Becton Dickinson medical director Hooman Noorchashm petitions FDA to warn patients about the unknown and inadequately studi...

ODAC Looking at Long Delays in 2 Acrotech Trials

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FDA asks the Oncologic Drugs Advisory Committee whether Acrotech Biopharmas plan to complete a confirmatory trial for two cancer d...

Cardinal Health Recalls Infusion Pump Syringes

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Cardinal Health recalls its latest version (6/2023) of its Monoject syringes branded as Cardinal Health Monoject syringes because ...

Comments on Cell & Gene Comparability Guide

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Four stakeholders comment on an FDA draft guidance on comparability of human cell and gene therapy products and suggest improvemen...

Imfinzi Phase 3 Trial Fails

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AstraZeneca says its Imfinzi failed to achieve statistical significance in the PACIFIC-2 trial in some non-small cell lung cancer ...

FDA Lawyer Nguyen Moves to Cooley

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Law firm Cooley adds 14-year FDA lawyer Son Nguyen to the firms Washington, DC office.