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

FDA’s “Dear Doc” Final Guidance Yields To One Industry Request, Denies Another

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency offers a sneak peek into final “Dear Health Care Provider Letters” guidance, decreasing some of industry’s burden, while refusing to cave on other requirements.

You may also be interested in...



How To Write An Effective Letter: FDA Advises Sponsors On Crafting Drug Alerts

Guidance on “Dear Doctor” letters says companies should evaluate the effectiveness of their communications – but solely for their own use.

FDA Standardizing “Dear Doc” Letters To Fix Problems With Recipients As Much As Senders

FDA appears to have found problems on both the senders’ and recipients’ sides of “Dear Health Care Provider Letters” and issued guidance recommending effectiveness assessments and formatting specifications in an attempt to give the correspondence more impact.

FDA Wants To Consult Before Manufacturers Send "Dear Doc" Letters

New draft guidance says talks will ensure information and target audience are correct. Letters also will take on a more standard format.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076076

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