Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Adverse Event Data In Labeling Should Be Updated More Frequently, FDA Says

Executive Summary

FDA is emphasizing that sponsors should make more of an effort to continuously update the adverse events sections of their products' labeling

You may also be interested in...



Labeling Rule Implementation Focuses On Subpopulations And Consistency

Subpopulation data is a growing area of interest: FDA's new labeling initiative does not adequately address the inclusion of subpopulation data, Office of Medical Policy Director Robert Temple acknowledged during a recent workshop on implementation of the revised format sponsored by the Drug Information Association and FDA. "There's also interest in the major demographic and other subgroup differences," Temple noted. "How much to make of those is a somewhat delicate matter, but this is another area of growing interest and I don't think it's actually, I hate to say this, well covered in the guidance....I don't know if you noticed this, but if you read the [New England Journal of Medicine] today, almost every outcome study will have what I've learned to call a forest plot. That's one of these things that shows the hazard ratios on a wide variety of subgroups....They're actually starting to show up in labeling and we've never really said very much about what to do with those things. Everybody knows you can't treat a subset finding the same way as the original...and yet there's tremendous interest in looking at consistency across the sub-groups. So I think it's something that needs more discussion"...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

UsernamePublicRestriction

Register

ID1132542

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