Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

DTC "Brief Summary" Should Refer To Other Treatment Options, Blues Tell FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Prescribing information for direct-to-consumer ads should include a tagline encouraging consumers to consult their doctors for other treatment options, the Blue Cross/Blue Shield Association comments on FDA's DTC draft guidances say.

You may also be interested in...



FDA "Brief Summary" Changes Should Be Written In Regs - PhRMA

DTC draft guidance creates a regulatory "Catch-22" by going against current regulations, PhRMA says in comments. FDA's guidance on disease awareness ads oversteps the agency's authority in regulating unbranded ads, the group asserts.

FDA "Brief Summary" Changes Should Be Written In Regs - PhRMA

DTC draft guidance creates a regulatory "Catch-22" by going against current regulations, PhRMA says in comments. FDA's guidance on disease awareness ads oversteps the agency's authority in regulating unbranded ads, the group asserts.

Alternatives To Brief Summary Outlined In Draft Guidance

One of FDA's three draft guidances on DTC advertising requests that consumer-friendly language be used. Commissioner McClellan calls proposed brief summary alternatives a "win-win" and suggests manufacturers will be able to reduce their advertising costs as a result.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS059371

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel