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Schering-Plough has reached an agreement with the Justice Department and the U.S. Attorney's Office for the Eastern District of Pennsylvania in which it will pay $345 million to resolve criminal and civil charges for illegal pricing activities.
The FDA is proposing to amend the final monograph for OTC nasal-decongestant drug products to remove the indication “for the temporary relief of nasal congestion associated with sinusitis” and to prohibit use of the terms “sinusitis” and “associated sinusitis” elsewhere in the labeling.
As the FDA prepares to issue a final guidance document on submitting pharmacogenomic data, the agency is in the early stages of developing a new guidance on how a genetic testing device could be co-developed with a drug or biologic to create a new combination product.
The FDA has warned a British Columbia device firm for failing to maintain adequate procedures under the quality system (QS) regulation or current good manufacturing practice (cGMP) requirements.
Diagnostics firm Clinical Diagnostic Solutions (CDS) was recently warned by the FDA for failing to comply with current good manufacturing practices at its Plantation, Fla., plant.
The FDA recently warned devicemaker Evermed for manufacturing hospital beds using methods that don't conform with current good manufacturing practices (cGMP).
St. Jude Medical last week split its Daig division into separate cardiology and atrial fibrillation AF units, reflecting the firm’s desire to explore the growth potential in its developing electrophysiology and catheter product lines.