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.
PhRMA has asked the Office of the United States Trade Representative to put the EU on notice for its plan to publish clinical trial data that currently is treated as confidential. Read More
The FDA released a draft guidance last month outlining requirements for submitting clinical study data in electronic format. Once finalized, submissions that do not conform to the standards, formats and terminologies outlined in the agency’s Data Standards Catalog will not be filed, the guidance warns. Read More
The EU’s new pharmacovigilance law could cost generic drugmakers fees totaling as much as $330,000 for each drug they make to cover postmarketing assessments. Read More
Drugmakers in the EU are pushing back against a proposal moving through the EU Parliament that would grant clinical trial participants the right to demand that their trial data — including data shared between regulators and other entities — be deleted. Read More
Sponsors should gather supportive data from two definitive clinical trials to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More
Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Both recalls were included in the FDA’s March 5 enforcement report. Read More
The European Medicines Agency (EMA) is calling on EU makers of seasonal influenza vaccines to develop enhanced safety signal monitoring systems that identify increases in allergic reactions, moving away from systems that simply check for specific batch deviations. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More