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The European Medicines Agency is asking sponsors to give two months’ advance notice of their intent to file orphan drug applications to help the agency meet its 90-day review deadline. Read More
Sponsors may be asked to provide the European Medicines Agency with additional data from failed trials to hone in on subpopulations where the treatment may be effective. Read More
The Scottish Medicines Consortium plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
The FDA and India’s Ministry of Health and Family Welfare signed a five-year accord that will allow them to share information from clinical trial inspections in their respective jurisdictions. Read More
Drugmakers are urging the FDA to publish extensive guidance on even the most basic issues related to clinical trial diversity as the agency steps up its efforts to increase diversity in clinical trial subject populations. Read More
Sponsors of new drugs and biologics for chronic pain may have to submit more safety data than they would to support acute pain candidates, an FDA draft guidance says. Read More
Institutional review boards that fail to write explicit policies defining clinical trial noncompliance are putting themselves and their research sites at risk, an industry expert says. Read More
The European Medicines Agency has denied a request by drugmakers to allow generic labeling of pandemic vaccines, saying such labeling would create too much ambiguity and make it hard to track and trace shipments of vials. Read More
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The FDA released a draft guidance last month outlining requirements for submitting clinical study data in electronic format.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