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Mylan 6-Item Form FDA-483 Posted

[ Price : $8.95]

FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing...

Sombra Cosmetics CGMP Violations

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FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.

FDA OKs Mesoblasts Ryoncil Cell Therapy

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FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.

Clinical Investigation Protocol Deviations

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.

Updated POLARx Instructions is Class 1 Recall: FDA

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FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.

CGMP Violations in Akorn Formulations Review

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FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...

CRL for Zealands SBS Treatment NDA

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FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.

Quality, Data Issues at Mylan Facility in India

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FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.

Boxed Warning for Veozah Liver Injury

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FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.

Lexicon Dropping Zynquista After CRL

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Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.