We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Office of Prescription Drug Promotion issued a warning letter to Shionogi, for omitting risks and material facts, for its head-lice lotion Ulesfia in a patient co-pay assistance voucher. Read More
British authorities say serious GMP deficiencies continue to plague Rusan Pharma’s Gujarat manufacturing facility, prompting them to reject all drugs from that site until it is compliant. Read More
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More
The European Medicines Agency and the European Commission published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Read More
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
The FDA is clarifying that if an institutional review board is found to be noncompliant, the FDA may require the IRB to withhold approval of new clinical studies, stop enrolling new subjects in ongoing studies, and to terminate ongoing studies. Read More