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

Fujisawa Prograf Risk Education Plan Requested By FDA Warning Letter

Executive Summary

Fujisawa will implement a Prograf risk education plan for physicians in response to FDA complaints that a journal ad for the organ rejection agent failed to present adequate risk information

You may also be interested in...



Bristol Pravachol investigation

Bristol-Myers Squibb receives civil investigative demand from Missouri Attorney General relating to Pravachol DTC advertising from 2001-2003, 1Bristol's 10-K filing says. A separate, class action 2complaint filed in Kansas City, Mo. state court alleges the ads misled consumers "into purchasing Pravachol under the mistaken belief that it would help prevent strokes in people with high cholesterol even if they did not have any history of heart disease." In an August 2003 warning letter, FDA said the ads falsely implied that pravastatin is approved for prevention of stroke in patients without coronary heart disease (3"The Pink Sheet" Aug. 11, 2003, p. 4). Bristol issued a corrective ad in February. [Editor's note: For more coverage, log on to 4"The Pink Sheet" DAILY. Visit our website, www.ThePinkSheetDAILY.com to sign up for a free trial.]...

DTC Battle: PhRMA Should Pay More Attention To Issue, Sen. Craig Says

The pharmaceutical industry will come under increased scrutiny for direct-to-consumer advertising of Rx drugs as a drug benefit is added to Medicare, Senate Special Committee on Aging Chairman Larry Craig (R-Idaho) suggested

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

UsernamePublicRestriction

Register

OM017181

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