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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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Notifying Applicants of Sentinel Analyses MAPP

[ Price : $8.95]

CDER issues a MAPP on policies and procedures for notifying NDA and BLA applicants about ARIA safety studies conducted in the Sent...

Public Workshop on Orthopedic Device Infections

[ Price : $8.95]

FDA announces an 11/13 public workshop on infections related to orthopedic devices and appropriate mitigation measures for protect...