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Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly revised guidance. Read More
A group of non-profits and activist organizations, including the American Lung Association, National Health Council and National Organization for Rare Disorders, urged lawmakers in the House of Representatives not to pass proposed right-to-try legislation. Read More
The FDA released new information for ANDA applicants on when to submit elemental impurity data, and acknowledged that new guidelines on reporting elemental impurities had slowed approvals in January. Read More
FDA Commissioner Scott Gottlieb offered an update on the agency’s plans to address the opioid epidemic, encourage market competition, and tackle internal agency issues, in remarks Tuesday to the Alliance for a Stronger FDA in Washington, D.C. Read More
Punishments for falsification of medicines in the European Union vary significantly between EU member states, according to a study carried out for the European Commission. Read More
Australia’s Therapeutic Goods Administration issued a survey to drugmakers asking about their pharmacovigilance activities with the intention of using the responses to prioritize inspections. Read More