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

Sen. Grassley Targets FDA's Handling Of Adderall XR Adverse Events

This article was originally published in The Pink Sheet Daily

Executive Summary

Finance Committee chairman expresses concern that agency may have sought to dissuade Health Canada from suspending Adderall XR sales because "FDA could not handle another 'drug safety crisis.'" Grassley requests records of FDA's meetings with Health Canada.

You may also be interested in...



FDA's Graham To Present Overview At COX-2 Advisory Committee Meeting

Office of Drug Safety Director for Science & Medicine David Graham is scheduled to present an "epidemiological overview" on Feb. 16, day one of the three-day meeting. Senate Finance Committee Chairman Charles Grassley is concerned that FDA has forbidden Graham from discussing certain data.

Shire Adderall XR Sales Suspended In Canada; FDA Stands By "Black Box"

Company plans a "Dear Doctor" letter informing U.S. physicians of Health Canada's decision. FDA says it "has not decided to take any further regulatory action at this time"; sudden death warnings were added to Adderall XR's labeling in August.

FDA Office Of Drug Safety “Separate But Unequal” To Office Of New Drugs, Senate Inquiry Finds

Finance Committee Chairman Grassley’s investigation into FDA’s handling of pediatric suicidality concerns with antidepressant drugs reveals ODS “serves a subservient” role to OND. Grassley points to allegations that OND discourages recommendations in drug consults.

Topics

UsernamePublicRestriction

Register

LL1134531

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