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Lee Medical Recalls Dialysis Prep Kits

[ Price : $8.95]

FDA says Lee Medical International has initiated a Class 1 recall involving its Custom Dialysis Trays/Kits.

Qualitest Pharma Recalls Oral Contraceptives

[ Price : $8.95]

Qualitest Pharmaceuticals recalls multiple lots of its oral contraceptives due to a packaging error.

Soligenix Stops Enrollment in orBec Trial

[ Price : $8.95]

Soligenix decides to stop patient enrollment in a confirmatory Phase 3 clinical trial involving orBec and its use in acute gastroi...

Virginia Cox Running FDA External Affairs

[ Price : $8.95]

FDA commissioner Margaret Hamburg says that Virginia Cox, a Clinton administration FDA outreach director, has returned to the agen...

FDA Cant Bar Veterinary Compounding: Court

[ Price : $8.95]

A Florida federal judge says that FDA doesnt have authority to regulate veterinary drug compounding from bulk ingredients.

Zofran Associated with Abnormal Heart Rhythms

[ Price : $8.95]

FDA says its ordering Zofran label revisions to include more information on an increased risk of QT prolongation leading to potent...

ICH Guidance on Veterinary Drug Comparative Metabolism Studies

[ Price : $8.95]

Federal Register Notice: FDA releases an ICH guidance on studies to evaluate the metabolism and residue kinetics of veterinary dru...

ICH Guidance on Residue Quantity/Nature of Veterinary Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases an ICH guidance on metabolism studies to determine the nature of residues from veterinary dr...

ICH Guidance on Electronic Data for Veterinary Pharmacovigilance

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on electronic standards for data transfer on the pharmacovigilance of veter...

Vivus, CDER Agreement on Weight-loss Drug Resubmission

[ Price : $8.95]

Vivus reaches agreement with FDA on an NDA resubmission of its weight-loss drug Qnexa (phentermine/topiramate) that includes a nar...