Drug Safety
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.
France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile.
New guidance from the European Medicines Agency explains how in vitro and in vivo models may be used instead of clinical data for the purpose of establishing therapeutic equivalence in a stepwise approach.
The US FDA Pediatric Advisory Committee uses web-posted reviews of “low safety risk” products to keep up with postmarketing monitoring requirements amid rising interest in pediatric development.
Long-term follow-up requirements have taken a conservative approach, but could be ripe for re-examination and global harmonization, Kite Pharma executive director says, while former FDA gene/cell therapy office head Wilson Bryan wants the classwide REMS eliminated.
An FDA question to a patient concerned about the negative impacts of the CAR-T boxed label warning during a recent listening session indicates the agency may be thinking about improving its dissemination of the information.
The withdrawal amid concerns about the risk-benefit ratio reduces treatment options for sickle cell disease, but it is not expected to have much effect on the SCD market, including the gene therapies.
Pharmacovigilance experts speaking at an event organized by the European Medicines Agency discussed the rationale behind revised requirements relating to how drug sponsors must develop and evaluate risk minimization measures and thereby improve the safety of their medicines.
New requirements proposed by the French regulator are intended to increase the impact and effectiveness of the pictogram showing the risks of taking medicines in pregnancy.