FDA issues prescription drug promotion guidance; FDA approves first follow-on biologic of Lilly’s Humalog; drugmakers allegedly hired nurses to promote drugs
Five things for pharma marketers to know: Wednesday, August 5
The FDA updates Gilenya’s label over definite case of PML; generic drug companies are consolidating for negotiating power; the FDA revises guidance on DTC risk information
Five things for pharma marketers to know, Thursday, June 4
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn’t.
FDA approves sNDA for Xeljanz
February 25, 2014
8:49 pm
The new label will reflect the RA pill’s superiority to methotrexate and placebo in inhibiting the progression of structural joint damage.
The FDA approval of 23-mg donepezil (Aricept) conflicted with the opinions of its own reviewers and breached the agency’s own regulatory standard, authors write in a BMJ article, leading to misleading consumer and physician ad campaigns that put patients at risk.
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