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 » FDA Lacks Policy to Deal With EU Falsified Medicines Directive, Shortage Concern Looms
FDA Lacks Policy to Deal With EU Falsified Medicines Directive, Shortage Concern Looms
The FDA’s lack of a policy or guidance to help API manufacturers deal with a new European directive is causing concern among manufacturers about lost sales and drug shortages in Europe, an expert says. Under the European Commission’s falsified medicines directive, all non-EU API makers must obtain written confirmation from their local regulatory authority to verify that APIs were manufactured according to good manufacturing practices equivalent with those in the EU. Drug Industry Daily