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FDA Approves Nonprescription Zyrtec-D for Allergies
The Food and Drug Administration (FDA) has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescriptio...

FDA Clears Silver-Coated Breathing Tube for Marketing
The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coati...

FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (
The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimu...

Oracle Fusion GRC Intelligence New Release Centralizes Risk and Compliance Information Across the Enterprise
Oracle announced the latest version of Oracle Fusion Governance Risk and Compliance (GRC) Intelligence. This release delivers expanded risk and compli...

FDA Clears for New Sprycel Product Labeling for Patients with Chronic-Phase CML
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for SPRYCEL to include a lower recom...

FDA Gives 510(k) Clearance to Baxter's New Antimicrobial Intravascular Technology
Baxter Healthcare Corporation announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its V-Link Luer-activat...

FDA-Approved Prescription Medications Now Available Online
As the political debate rages over the nuances of the American healthcare system, individuals are becoming more apprehensive about the prices of their...

15 Voting Members to Serve on FDA's Risk Communication Advisory Committee
The U.S. Food and Drug Administration has selected 15 voting members to serve on its Risk Communication Advisory Committee. The Committee will advise ...

Quality Associates Wins Major FDA Contract
Quality Associates, an established provider of services and solutions for document management, imaging and archiving, announced that it has been award...

Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex(R) With Codeine
Adams Respiratory Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Appl...

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