Drug Safety
Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.
The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.
The Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concerns
A new EU public-private initiative is developing tools to help clarify when mini- and micropig models can be used as viable alternatives to non-human primates in non-clinical drug safety testing.
The US FDA is expected to refine warnings recently added to CAR-T cell therapies about the risk of secondary malignancies after reassuring new data, which is a positive sign for the future of the therapies in autoimmune disorders.
The Risk Evaluation and Mitigation Strategy hindered access and burdened the health care system even though it was never fully implemented or enforced. The FDA still recommends prescribers monitor patients’ absolute neutrophil count to prevent severe neutropenia.
The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.
Robert F. Kennedy Jr.'s Make America Healthy Again Commission will solicit public "expertise" in open forums, which could enable defenses of vaccines and certain drugs the panel is targeting. Seven members so far have been tapped.
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.