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 » OPDP: Social Media Guidance Will Be High Priority in 2013
OPDP: Social Media Guidance Will Be High Priority in 2013
The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014. Drug Industry Daily