The FDA attempts to understand how disclosures affect drug ads

The FDA attempts to understand how disclosures affect drug ads

The FDA recently proposed studies designed to determine how disclosures in drug ads affect how viewers frame information.

Astellas reprimanded by U.K. drug regulator

Astellas reprimanded by U.K. drug regulator

The drugmaker has been handed a "public reprimand" by the U.K.'s Prescription Medicines Code of Practice Authority after the creative director of an unnamed agency used the company's patient support materials on its website.

PDUFA amendment would broaden off-label rules

PDUFA amendment would broaden off-label rules

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

The FDA cites risk info in letter over Contrave DTC ad

The FDA cites risk info in letter over Contrave DTC ad

The regulator also took issue with how Orexigen Therapeutics presented the risk information

What marketers need to know about tax reform, off-label promotion, pricing

What marketers need to know about tax reform, off-label promotion, pricing

The ad-tax deduction is likely once again on the table.

Califf calls for marketers to develop off-label 'code of ethics'

Califf calls for marketers to develop off-label 'code of ethics'

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

Amgen, Sandoz argue biosimilar patent case to the Supreme Court

Amgen, Sandoz argue biosimilar patent case to the Supreme Court

Sandoz counsel argued that Amgen's position "wrongly delays the marketing of every biosimilar."

Senate committee launches investigation into opioid marketing

Senate committee launches investigation into opioid marketing

The committee is seeking information about the companies' sales and marketing strategies.

Veeva and QuintilesIMS tussle over customer reference data

Veeva and QuintilesIMS tussle over customer reference data

Veeva is countersuing QuintilesIMS in the wake of allegations that Veeva mishandled its proprietary data.

Industry groups petition the FDA over off-label rule

Industry groups petition the FDA over off-label rule

PhRMA, BIO, and the Medical Information Working Group filed a citizen petition over a final rule they say raises risks for drugmakers.

FDA guidance seeks to clarify pharma comms with payers

FDA guidance seeks to clarify pharma comms with payers

But it may also increase the reporting burden for drugmakers.

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

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

The FDA targeted DTC, video, unapproved drug promotion in 2016

The FDA targeted DTC, video, unapproved drug promotion in 2016

The agency issued 11 enforcement letters last year.

The FDA to study whether people can recognize misleading drug ads

The FDA to study whether people can recognize misleading drug ads

The agency has faced questions about how it regulates off-label communications.

The FDA issues untitled letters to Sanofi and Celgene over distracting ads

The FDA issues untitled letters to Sanofi and Celgene over distracting ads

Regulators said the ads distract viewers from superimposed safety information.