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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The FDA released a draft guidance last month outlining requirements for submitting clinical study data in electronic format.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
The FDA on Feb. 25 released new information that shows the scope of its efforts to investigate the efficacy and bioequivalence of generic drugs, publishing summaries of ongoing research. Read More
FDA efforts to standardize capsule and tablet sizes for generic drugs are unnecessary and will strain relationships with suppliers, generic drugmakers say. 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
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. 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 FDA is voicing new safety concerns with the next-generation heart drugs known as PCSK9 inhibitors, asking drugmakers to flag any neurocognitive adverse events associated with the class of drugs. Read More