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Latest From Drug Safety
US FDA has made efforts to improve health communications to cater to deficiencies in literacy; other specific topics for discussion at the meeting remain unclear.
New data from J&J's cardiovascular outcomes trials shows leg and foot amputations occurred about twice as often in diabetes patients treated with canagliflozin versus placebo.
“The present has passed us by” in using appropriate technology to provide consumers more information than on US Drug Facts labels, Pinney Associates’ Saul Shiffman says at CPHA conference.
US drugs with accelerated approval are more likely to experience a postmarket safety event, JAMA study finds; data sharing could be a solution to filling information gaps.
Amendment from Sen. Sanders was tabled in part to avoid adding a controversial provision that could slow the bill's passage, but may be debated during upcoming drug costs hearing.
Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.
Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.
Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.
US FDA’s approval of Mitsubishi's Radicava (edaravone) is yet another demonstration of the agency’s flexibility for drugs to treat rare diseases – and pre-emptive action to fend off “Right to Try” laws. It is also a belated endorsement of one of the stranger votes by an FDA advisory committee member almost a decade ago.
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