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Remote Medication System into Class 2

[ Price : $8.95]

Federal Register Final rule: FDA classifies the remote medication management systems into Class 2 with a guidance serving as the s...

Guidance on Mechanical Calibration CGMPs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on the current good manufacturing practices for the use of mechanical calib...

FDA Approves Humate-P Storage Conditions Change

[ Price : $8.95]

FDA has approved new storage conditions for CSL Behrings Humate-P that remove refrigeration requirements.

Science Board Meeting Date Changed

[ Price : $8.95]

Federal Register Notice: FDA changes the date of the meeting of the Science Board to the FDA to 12/3.

FDA Tentatively OKs Impaxs Generic Effexor

[ Price : $8.95]

FDA tentatively approves an Impax Labs ANDA for a generic version of Wyeths Effexor XR.

Pfizer Dumps Inhaled Insulin Exubera

[ Price : $8.95]

Pfizer decides to abandon its inhaled insulin product Exubera after disappointing sales and physician resistance.

FDA Approves Doribax

[ Price : $8.95]

FDA approves J&Js Doribax for treating complicated urinary tract and intra-abdominal infections.

Remote Medication Management System

[ Price : $8.95]

FDA issues a guidance in conjunction with a notice classifying remote medication management systems as Class 2.

Dissolution Calibration Guidance

[ Price : $8.95]

CDER publishes a guidance on using mechanical calibration as an alternate to calibrator tablets in dissolution testing apparatus.

CVM Should Stop Approving Human-use Antibiotics

[ Price : $8.95]

Consulting editor John Scharmann reviews CVMs recent approval of florfenicol in the light of growing concern about antibiotic-resi...