Day: June 9, 2016

FDA and EMA have been increasingly harmonizing regulatory requirements in Europe and US for most drug and biological products for the last two decades and it seems soon they may get even closer. This week European Medicines Agency (EMA) released a report disclosing ongoing discussions with FDA to set up ground rules for simultaneous review and approval of drugs, … Read more

Patient perspectives could be vastly different from that of the drug developers and regulators in terms of the benefits and risks of existing therapies, the medical need and relevant endpoints for clinical trials. In the recent years, FDA has aggressively courted patients to provide opinions about the regulatory review process through its Patient Focused Drug Development … Read more