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 » British Drugmaker Cited for cGMP, Misbranding Violations
British Drugmaker Cited for cGMP, Misbranding Violations
British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials. Nelson had not identified a corrective and preventive action plan to reduce future occurrence, according to the warning letter, posted recently online. It also failed to determine if a potentially affected product was released for distribution. Drug GMP Report