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FDA Recognizes RiduZone as a New Dietary Aid

[ Price : $8.95]

NutriForward says FDA has recognized its RiduZone as a new dietary supplement that supports healthy weight, appetite, body-fat com...

CBER Guidance on Gene Therapy Shedding Studies

[ Price : $8.95]

CBER posts a guidance on Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy (VBGT) and Oncolytic Pro...

QS Issues Found at New May King Plastic

[ Price : $8.95]

FDA warns Chinas New May King Plastics about 12 Quality System violations in its manufacturing of Class 1 and 2 massagers.

Allergan Recalls Ophthalmic Products Due to Black Particles

[ Price : $8.95]

Allergan recalls several lots of its ophthalmic ointments due to reports about small black particles present in the products.

Import Alert on Cane Infusion Pumps After Inspection

[ Price : $8.95]

FDA issues an import alert to refuse entry into the U.S. infusion pumps made by Cane SpA (Rivoli-Turino, Italy).

Amgen NDA for Kidney Disease-associated Hyperparathyroidism

[ Price : $8.95]

Amgen files an NDA for etelcalcetide for treating secondary hyperparathyroidism in patients with chronic kidney disease on hemodia...

FDA Approves Dexcom Mobile Glucose Monitor

[ Price : $8.95]

FDA approves a Dexcom PMA for its Dexcom G5 Mobile Continuous Glucose Monitoring System.

FTC Takes New Type of Enforcement Action: Blog

[ Price : $8.95]

Attorneys Bruce Sokler and Farrah Short outline a new type of FTC enforcement action used in a consent order with Concordia and Pa...

PhRMA Faults FDA on REMS Changes Guidance

[ Price : $8.95]

PhRMA criticizes FDA for saying in its guidance on REMS modifications and revisions that the document is binding and did not need ...

Cepheid Ab Inspection Finds QS Issues

[ Price : $8.95]

FDA warns Swedens Cepheid Ab about Quality System violations in its manufacturing of the Xpert Norovirus.