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


ASCO Maintains Clinical Trials Could Be Hindered Under Medicare 2005 Part B Payments

This article was originally published in The Pink Sheet Daily

Executive Summary

Reductions in Medicare payments over 2005 could hamper clinical trial enrollment, former ASCO President Margaret Tempero, MD, said during a Capitol Hill briefing Sept. 8

You may also be interested in...

Procrit, Gemzar, Camptosar At Risk Under 2005 Medicare Payment Rates, ASCO Says

CMS estimates the total drop in Medicare payment reductions for 2005 at 8%; an ASCO survey of community clinics found a 15% payment reduction. ASCO seeks legislation establishing a floor in total payments through 2006.

Lupus Guidance Suggests Broad Use Of Health-Related Quality Of Life Endpoint

FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.

Risk Management Guidance Suggests Using Claims Data To Evaluate Safety Signals

Three FDA risk management final guidances recommend that sponsors collect a wide range of safety data during both the clinical trial and postmarketing periods of drug development. The agency suggests that sponsors hold discussions with FDA before settling on drug study designs or postmarketing activities.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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