A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.
Home » Supplier Glass Vial Defects Prompt Health Canada Warning on Hospira Cancer Drug
Supplier Glass Vial Defects Prompt Health Canada Warning on Hospira Cancer Drug
Hospira is looking into a supplier glass defect following consumer complaints and a Health Canada warning to physicians not to use three lots of its cancer treatment paclitaxel injection, 300 mg/50 mL. Complaints to the company from outside Canada described particles embedded in the glass vial, rust-like marks on the vial and particles in the solution, the agency said. Hospira to date has not received any adverse event complaints for the lots. Drug Industry Daily