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 » Study Finds Quality Problems in WHO-Approved Drugs Made in China
Study Finds Quality Problems in WHO-Approved Drugs Made in China
Chinese-made drugs approved by the World Health Organization (WHO) are seven times more likely to be substandard, degraded or counterfeit than similar Indian-made drugs approved by the WHO, according to a new study. The study, published in Research and Reports in Tropical Medicine, looked at 2,652 essential drugs to treat malaria, tuberculosis and bacterial infections from 11 African cities, three Indian cities and five other cities in mid-income countries. Drug GMP Report