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Transplant Viral Nucleic Acid Tests in Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies quantitative viral nucleic acid tests for transplant patient management into Class 2 (spec...

Integrating RCTs into Routine Clinical Practice

[ Price : $8.95]

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

Safety Alert on Zimmer Hip System

[ Price : $8.95]

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

[ Price : $8.95]

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

CGMP Violations at TJA Health

[ Price : $8.95]

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

Quality CDMO Marketing Unapproved Drugs: FDA

[ Price : $8.95]

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

Consider Phased DSCSA Enforcement: PhRMA

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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