Off-label

All articles by Off-label

Five things for pharma marketers to know: Friday, January 19, 2018
Five things for pharma marketers to know: Friday, January 19, 2018
Virginia Lau
January 19, 2018
3:00 pm

Biogen, UCB reportedly showing interest in Acorda acquisition; Kite Pharma and Pfizer to develop combo lymphoma therapy; hospitals to form generics nonprofit

Five things for pharma marketers to know: Tuesday, January 16, 2018
Five things for pharma marketers to know: Tuesday, January 16, 2018
Virginia Lau
January 16, 2018
3:20 pm

Merck’s Keytruda combo therapy succeeds in Phase-III lung cancer trial; FDA launches pilot to address trial transparency; Spark’s Luxturna overpriced, ICER says

PDUFA amendment would broaden off-label rules
PDUFA amendment would broaden off-label rules
Kevin McCaffrey
June 7, 2017
2:35 pm

The bill, introduced in March, is being considered as an amendment in the upcoming PDUFA reauthorization legislation.

Califf calls for marketers to develop off-label ‘code of ethics’
Califf calls for marketers to develop off-label ‘code of ethics’
Kevin McCaffrey
May 16, 2017
2:15 pm

The former FDA commissioner said marketers need to focus on ensuring that off-label promotion is “non-misleading.”

Off-label legal settlements do little to change prescribing patterns
Off-label legal settlements do little to change prescribing patterns
Kevin McCaffrey
April 11, 2017
8:49 pm

An analysis of claims data found that an off-label settlement for one Eli Lilly drug did not significantly change how often it was prescribed off-label after the settlements.

Five things for pharma marketers to know: Friday, March 17, 2017
Five things for pharma marketers to know: Friday, March 17, 2017
Virginia Lau
March 17, 2017
2:36 pm

The FDA delays final rule related to off-label use; Amgen’s Repatha reduces risk of death by 20%, study finds; FDA rejects AstraZeneca’s hyperkalaemia drug

Gottlieb Likely to Take On Off-Label, Predictability at the FDA
Gottlieb Likely to Take On Off-Label, Predictability at the FDA
Peter Pitts, Center for Medicine in the Public Interest
March 16, 2017
2:25 pm

In short, he’ll be further along the learning curve than anyone ever tapped for the nation’s number-one public health regulatory slot.

Why President Trump Won’t Overhaul the FDA
Why President Trump Won’t Overhaul the FDA
Wayne Pines, APCO Worldwide
February 27, 2017
7:00 pm

In short, the Trump team, I predict, will seek to tweak FDA.

In draft guidance, the FDA defines appropriate off-label comms as being ‘consistent’ with the label
In draft guidance, the FDA defines appropriate off-label comms as being ‘consistent’ with the label
Kevin McCaffrey
January 19, 2017
3:40 pm

The regulator is providing examples of appropriate off-label communications.

Five things for pharma marketers to know: Thursday, January 19, 2017
Five things for pharma marketers to know: Thursday, January 19, 2017
Kevin McCaffrey
January 19, 2017
3:32 pm

The FDA releases three documents; PBM rebates eating into drugmaker revenue: PhRMA; most oncologists on Twitter receive money from pharma

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