Drug Safety
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.
The European Commission has registered a European citizens' initiative that explains how the EU can foster equitable, timely, affordable, safe and legal access to innovative psychedelic-assisted treatments. Work towards securing the one million signatures needed for the next step is starting soon.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
The World Health Organization says its new 98-page guidance dealing with wastewater and solid waste management for antibiotic manufacturing is a first of its kind and addresses an important but neglected issue.
The deadline is nearing for pharmacopoeias to express their interest in joining the decades-old discussion group that works to harmonize excipient monographs and general chapters and reduce the burden on manufacturers to perform analytical procedures in different ways depending on the jurisdiction.
While pharmacovigilance requirements for medicines in the UK will remain “broadly in line” with current rules from 1 January 2025, companies should be aware of changes for some products after this date, the UK’s MHRA says.
Medsafe is seeking feedback on proposals to update its clinical trials guidelines, and on two new guidance documents, one of which is dedicated to the “specific considerations” relating to the review and approval of first-in-human studies.
India prohibits the manufacture and sale of over 150 fixed-dose combinations (FDCs) that lack therapeutic justification and pose potential health risks, though all eyes are on how effectively the regulatory apparatus enforces the ban, not the first in the area, amid legal action. One firm has secured an ad interim ruling for its combination drug.
Brazil looks to EU, UK and others for inspiration on introducing a regulatory sandbox.
Principal deputy commissioner Bumpus agrees with advisory committee findings that safety issues with ITCA 650 preclude approval, regardless of comparisons to other diabetes treatments. Final order caps a nearly eight-year regulatory saga that has grown increasingly rancorous.
It is “absolutely fundamental” that manufacturers of cell and gene therapies interact with inspectors from regulatory agencies to understand their expectations around good manufacturing practice, a compliance consultant at CDMO eXmoor pharma says.
A direct communication to health care professionals says that the initial symptoms of anaphylaxis with glatiramer acetate might overlap with those of post-injection reactions and could lead to a delay in identifying an anaphylactic reaction.
Drug companies may have to adjust their benefit-risk management strategies to ensure compliance with the European Medicines Agency’s newly revised guidance on how to develop and evaluate risk minimization measures.