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Integrating RCTs into Routine Clinical Practice

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FDA publishes a guidance on integrating clinical trials into routine clinical practice.

Safety Alert on Zimmer Hip System

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FDA issues a safety alert about an increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip S...

Decentralized Clinical Trial Guidance

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FDA publishes a guidance on the conduct of clinical trials with decentralized elements.

CGMP Violations at TJA Health

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FDA warns Joliet, IL-based TJA Health about CGMP violations in its manufacturing of finished drugs.

Quality CDMO Marketing Unapproved Drugs: FDA

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FDA warns Fort Worth, TX-based Quality CDMO that it is marketing five unapproved new drugs.

Consider Phased DSCSA Enforcement: PhRMA

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PhRMA asks FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act because many drug company trading par...

Kisqali Expanded Approval for Early Breast Cancer

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FDA approves an expanded use for Novartis Kisqali (ribociclib) combination use with an aromatase inhibitor for the adjuvant treat...

FDA Lifts Partial Clinical Hold on Alzheimers Drug

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FDA lifts a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule t...

CGMP Violations at Italian Drug Plan

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In an untitled letter, FDA says Milan, Italy-based Industria Farmaceutica is manufacturing drugs with CGMP violations.

FDA Extends Treosulfan NDA Review by 3 Months

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Medexus Pharmaceuticals says FDA has extended the review of its Medac licensors resubmitted NDA for treosulfan and its use in allo...