In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label

In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label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.

The FDA extends deadline for off-label input

The previous deadline was January 9.

Five things for pharma marketers to know: Wednesday, December 14, 2016

Five things for pharma marketers to know: Wednesday, December 14, 2016

Obama signs 21st Century Cures Act into law; the FDA approved 19 new drugs in 2016; Sanofi in talks to acquire Actelion

Senate passes Cures Act, which opens door to use of real-world evidence

Senate passes Cures Act, which opens door to use of real-world evidence

The bill now heads to President Obama's desk. He is expected to sign the sweeping piece of legislation.

House passes 21st Century Cures Act that would allow some off-label sharing

House passes 21st Century Cures Act that would allow some off-label sharing

The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.

Pharma pushes to share off-label info with payers at FDA hearing

Pharma pushes to share off-label info with payers at FDA hearing

Insurers and pharmacy benefit managers already have a sophisticated understanding of clinical data, the industry argued.

5 questions raised at the FDA's off-label hearing

5 questions raised at the FDA's off-label hearing

The FDA asked questions about the risks and benefits of allowing off-label communications.

Off-label promotion: By the numbers

Off-label promotion: By the numbers

Here are 5 statistics about off-label promotion ahead of the FDA's public hearing this week.

Will drugmakers get what they're looking for at this week's FDA off-label hearing?

Spurred by recent lawsuits, the FDA is scheduled to hold a two-day hearing this week on whether to allow drugmakers more latitude in promoting therapies off-label.

FDA charges KOL with misbranding seizure drug in promo video

FDA charges KOL with misbranding seizure drug in promo video

Supernus Pharmaceuticals received an untitled letter over a promotional video for Oxtellar XR.

Warning letters most often stem from missing risk information

Warning letters most often stem from missing risk information

The number of warning and untitled letters has dropped in recent years. Only four letters have been sent so far this year, compared to 28 in 2012.

Drugmakers spar with FDA over proposed DTC animation study

Drugmakers spar with FDA over proposed DTC animation study

The FDA responded to criticism from industry about its proposed research of DTC animation.