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The congressional drumbeat of opposition to Zogenix’s painkiller Zohydro ER continues, with two Democratic senators ratcheting up the rhetoric by calling for HHS to revoke the controversial drug’s approval. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. Read More
Generic drugmakers in the EU must create a program to assess the effectiveness of their risk minimization efforts for each marketed drug, EU regulators say. Read More
Beginning on June 16, whenever a drugmaker receives approval for a generic drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. 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biologics for chronic pain may have to submit more safety data than they would to support acute pain candidates, an FDA draft guidance says.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
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
The FDA released a draft guidance last month outlining requirements for submitting clinical study data in electronic format.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
FDA efforts to standardize capsule and tablet sizes for generic drugs are unnecessary and will strain relationships with suppliers, generic drugmakers say. 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
Drug safety assessors in the EU are urging tougher restrictions on drugs containing domperidone used in anti-vomiting treatments such as Janssen’s Motilium, due to potential heart risks. Read More