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FDA Rebuffs BioMarin BLA for Hemophilia Gene Therapy

[ Price : $8.95]

FDA issues a complete response letter for a Phase 3 trial of BioMarins gene therapy for severe hemophilia A.

Covid-19 Inspection Questions and Answers

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FDA issues an immediately effective guidance to answer questions about some regulatory and policy issues during the Covid-19 publi...

ANDA Consolidation MAPP

[ Price : $8.95]

CDER issues a MAPP on ANDA consolidation procedures.

IlluminOss Photodynamic Fibula Stabilizer Cleared

[ Price : $8.95]

FDA clears an IlluminOss Medical 510(k) for its Photodynamic Bone Stabilization System for treating fibula fractures.

Hyperfine Research Portable MRI Expanded Use

[ Price : $8.95]

FDA clears a Hyperfine Research 510(k) to expand the use of its portable Swoop MRI imaging device to expand its brain imaging indi...

Oxford Selling Unapproved, Misbranded Covid Items: FDA

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FDA warns Oxford Medical Instruments that it is marketing unapproved and misbranded new drugs and claiming they can treat Covid-19...

Changes to FDA Organization Structure

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Federal Register notice: FDA revises its regulations to reflect changes to the agencys organizational structure, including the reo...

Info Collection Extension on CVM Dispute Resolutions

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for CVM dispute resolution procedures.

BA, BE Sample Retention Compliance Guidance

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FDA publishes a guidance with its compliance policy on the retention of reserve samples of the test article and reference standard...

SilveryGuy Selling Unapproved Colloidal Silver: FDA

[ Price : $8.95]

FDA warns a Singapore-based Web site that it is selling an unapproved and misbranded colloidal silver drug product intended to tre...