Drug Safety
The UK drug regulator says that men under the age of 55 years who are already taking valproate will not need to be reviewed by two specialists, as this measure is “unlikely to minimize risks” of neurodevelopmental disorders in children conceived by them any further.
President Trump's Executive Order creating the commission names mental health and weight-loss drugs as treatments of concern. But it does not mention vaccines, which Kennedy has criticized.
General chapters on pyrogens, histamine and depressor substances – involving tests on rabbits, guinea pigs and cats – are being removed from the Ph. Eur, marking another step in the European Pharmacopoeia Commission’s ongoing efforts to replace, reduce and refine the use of animals for monograph requirements.
The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.
When finalizing its guidance on the use of follow-up questionnaires to obtain additional information on an adverse reaction, the European Medicines Agency has addressed some of industry's concerns, but retained requirements for detailed analysis and outcome indicators.
Health and Human Services Department Secretary nominee Robert F. Kennedy Jr. falsely said prescription drugs are the third leading cause of death and made other comments on corporate capture, mifepristone, anti-depressants, and ADHD treatments, suggesting someone who often sows doubt and misleads on the risk-benefit balance of pharmaceuticals.
Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.
Europe’s public-private Innovative Health Initiative is seeking contenders for two research projects relevant to pharmaceuticals, one relates to the incoming European Health Data Space Regulation and the other focuses on reducing exposure to medicines containing per- and polyfluoroalkyl substances.
Stakeholders have until 15 January to respond to a European Commission proposal that aims to harmonize pharmacovigilance activities by marketing authorization holders, national competent authorities and the European Medicines Agency.
The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.
The European Medicines Agency says it will take appropriate measures to update the Ozempic’s package leaflet if new evidence arises.
The FDA's view that current monitoring recommendations may not be sufficient to mitigate harm increases the likelihood it could seek withdrawal.
The FDA wants to update 2017 requirements for the data needed before initiating RSV vaccine trials in infants and toddlers after vaccine-associated enhanced respiratory disease triggered an indication-wide research hold.
The FDA and sponsors should have surveyed providers and patients who do not prescribe or use the antipsychotic clozapine to find whether the REMS restrictions were hindering access and causing harm, advisory committee members and patient advocates said.
The US FDA seeks to better understand and predict insertional mutagenesis in gene therapies like bluebird bio's Skysona, which use integrating viral vectors, but a workshop on integration site analysis highlighted the approach's complexity and limitations.
The atypical antipsychotic’s Risk Evaluation and Mitigation Strategy should be retired because the requirements for prescriber education and documentation on absolute neutrophil count monitoring are hindering access, panelists said.
The confirmatory trial for the anticoagulant reversal agent raised safety and efficacy concerns from the agency.
The antipsychotic’s Risk Evaluation and Mitigation Strategy has never been fully implemented or enforced due to operational and technical challenges. The FDA now is re-evaluating the need for the program given changes in the health care landscape and medical training since the drug’s 1989 approval.
After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit for a restricted population and with a recommendation for ongoing safety scans.
Companies submitting individual case safety reports in Pakistan will soon have to use a new e-Reporting system that is expected to simplify and streamline the submissions process.