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 to Weigh Drugmakers’ Cargo Theft Response Plans, SOP States
FDA to Weigh Drugmakers’ Cargo Theft Response Plans, SOP States
The FDA is stepping up its handling of pharma and device cargo thefts, creating a cargo theft response team (CTRT) to assess companies’ action plans after a theft occurs. The team will also assess the risk to public health from the compromised products, according to a new FDA standard operating procedure (SOP) on cargo thefts. Drug GMP Report