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 Oral Contraceptives Guidance "Oversimplifies" Risk Information, J&J Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Johnson & Johnson is concerned that the draft guidance will not "objectively relate the risks" to physicians. The company also recommends including newer references for risk information.

You may also be interested in...



Oral Contraceptive Labeling Likely To Become More Graphic

FDA is nearing completion of guidance on labeling for combined oral contraceptives with an eye toward improving communication with more visual presentations rather than relying on prose.

FDA Oral Contraceptives Labeling Guidance Removes Mention Of Emergency Use

First draft of guidance listed dosing regimens appropriate for emergency use; PhRMA questioned inclusion of the information in earlier comments.

“Whistleblower” Suits Should Be Encouraged By Rx Manufacturers, Sen. Grassley Says

Schering-Plough’s Claritin settlement prompts letter from Grassley to Schering and 18 other manufacturers. Educating employees about the False Claims Act and their right to file suit is a “step in the right direction” to address fraud, he says.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS059547

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