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Latest From Drug Safety
Drug Safety: Sequential Surveillance Helps Regulatory Decision-Making, But Hurt By Premature Specification
IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body
US FDA officials, drug sponsors discussing creation of library of adverse event rates.
Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.
The European Medicines Agency wants to hear testimonies from the public about serious side effects that have been observed in patients treated with quinolone- and fluoroquinolone-containing medicinal products.
Language used to describe drug effects on pregnancy and lactation is ambiguous, complex and not useful to prescribers, advisors say, also urging FDA to use graphics or rating scales to convey the strength of the animal and human data on use during pregnancy.
Sandoz-led review of 90 published studies finds no evidence to support theoretical concern about differences in immunogenicity when switching between reference biologics and their biosimilars; findings could instill more public confidence about biosimilars in US and reduce importance of an interchangeability designation from FDA.
Biogen/AbbVie’s Zinbryta is already being withdrawn worldwide, but EMA now wants the MS drug recalled after mounting reports of serious brain disorders.
FDA is getting justifiably high marks for its efforts to accelerate drug development, and the proactive communication approach of Commissioner Gottlieb is a big part of that dynamic. But a drug safety withdrawal could be a sign of trouble ahead, if the perception takes hold that Europe is more proactive when it comes to patient safety.
EMA safety investigation pushes decision as AbbVie, Biogen acknowledge 'characterizing the evolving benefit/risk profile … will not be possible going forward given the limited number of patients being treated.'
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