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.
Following an FDA import alert placed on a Chinese API manufacturer early last month, the World Health Organization was left without a prequalified source for the birth control drug levonorgestrel, also known as Plan B. Read More
Congress Friday unveiled its first draft of FDA user fee reauthorizations, with total dollar amounts in line with those previously negotiated by regulated industry. Read More
In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Read More
Shire ViroPharma has asked a Delaware federal court to dismiss an FTC complaint accusing the drug company of abusing the citizen petition process. Read More
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More
The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed as required in ICH Good Clinical Practice guidelines. Read More
The Trump administration’s federal hiring freeze officially ended yesterday — but OMB Director Mick Mulvaney has warned the FDA and other federal agencies to prepare for deeper, long-term staff cuts. Read More