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The FDA released a draft guidance last month outlining requirements for submitting clinical study data in electronic format.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
Endo Pharmaceuticals has overcome three complete response letters for its low testosterone treatment Aveed, winning FDA approval for the injectable with a robust risk mitigation program. Read More
After six years of uncertainty, the FDA has lifted a clinical hold on trials of Oxygen Biotherapeutics’ Oxycyte intravenous emulsion, reviving hope for the drugmaker’s traumatic brain injury treatment. Read More
The FDA has rejected a diabetes drug co-developed by Boehringer Ingelheim and Eli Lilly due to unresolved quality issues at one of Boehringer’s plants. Read More
Sponsors planning on sending lot release samples to CBER in May and June should plan to delay until after the center relocates to the FDA’s White Oak headquarters in Silver Spring, Md. Read More