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.
An FDA memo outlining restrictions on communications over unapproved uses could restrict the flow of important information, and conflict with a company’s freedom of speech, say drugmakers and industry groups. 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 EMA is planning to focus on 13 separate initiatives for 2017, ranging from fully implementing its priority medicines review pathway to boosting international cooperation. Read More
The Senate health committee has scheduled its vote on the nomination of Scott Gottlieb to be the next commissioner of the FDA — for April 26. Read More
The FDA issued Targeted Medical Pharma a warning letter for failing to submit an IND application prior to beginning clinical investigations for a product the agency deemed to be a drug. Read More