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Kremers Urban Generic Concerta Downgraded Due to BE Concerns

[ Price : $8.95]

FDA tells Kremers Urban Pharmaceuticals that it will need to conduct an additional bioequivalence study based on a recently issued...

Industry Wants More Guidance on Biomarker Use in Trials

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America says FDA should develop a guidance document on conducting trials in biomarker...

Comments Sought on Export Certificate Requirements

[ Price : $8.95]

Federal Register Notice: FDA invites comments on information collection requirements for firms intending to export FDA-regulated p...

Janssens Invega Sustenna Approved for Schizoaffective Disorder

[ Price : $8.95]

FDA approves a Janssen Pharmaceuticals supplemental NDA for the once-monthly atypical antipsychotic Invega Sustenna (paliperidone ...

FDA Clears SQI Diagnostics Celiac Assay

[ Price : $8.95]

FDA clears a SQI Diagnostics 510(k) to market its proprietary Celiac Panel, an Ig plex Celiac DGP in vitro diagnostic test.

FDA Clears Allergan PMA for New Breast Implants

[ Price : $8.95]

FDA approves an Allergan PMA to market two new styles, X and L, of the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-F...

Comments Sought on Rx Drug Administrative Procedures

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on information collection in the Prescription Drug Marketing Act of 1987 Administrati...

Comments Sought on New Dietary Ingredient Safety Procedures

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the procedure for dietary supplement manufacturers to submit to FDA information abo...

Comments Sought on Rx DTC Ad Research

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on research on a spouses influence on a consumers understanding of direct-to-consumer ...

Blood Panel Agenda Changed

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Federal Register Notice: FDA amends a 10/22 notice of the Blood Products Advisory Committee to note an agenda change in which the ...