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 Refuse-To-File Policy Records Requested Under House ImClone Probe

Executive Summary

The House Commerce/Oversight Subcommittee is asking FDA to provide records relating to its policy on refuse-to-file letters, as part of its broadening investigation into ImClone

You may also be interested in...



Special protocol assessment final guidance

FDA's 1special protocol assessment guidance, issued May 17, makes "minor changes" to the draft "to make the document more clear." The draft guidance was released in February 2000 (2"The Pink Sheet" Feb. 14, 2000, p. 18). The House Commerce/Oversight Subcommittee is examining special protocol assessments in connection with its investigation into ImClone's BLA for Erbitux (3"The Pink Sheet" March 25, p. 20)...

Special protocol assessment final guidance

FDA's 1special protocol assessment guidance, issued May 17, makes "minor changes" to the draft "to make the document more clear." The draft guidance was released in February 2000 (2"The Pink Sheet" Feb. 14, 2000, p. 18). The House Commerce/Oversight Subcommittee is examining special protocol assessments in connection with its investigation into ImClone's BLA for Erbitux (3"The Pink Sheet" March 25, p. 20)...

House Erbitux probe

Hearings stemming from the House Energy & Commerce investigation of ImClone and its BLA for Erbitux are not likely to happen this year, Health Subcommittee Chairman Michael Bilirakis (R-Fl.) told reporters April 16. Committee Chairman Billy Tauzin (R-La.) added: "Staff has been meeting with FDA and stakeholders, but there has been no decision made as of yet." The House investigation is focusing on ImClone's representations to shareholders regarding the oncologic product and may include FDA review policies (1"The Pink Sheet" March 25, p. 20)...

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS039536

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