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

Sen. Grassley's Proposed Drug Safety Office Would Have Labeling Authority

This article was originally published in The Pink Sheet Daily

Executive Summary

Finance Committee chairman is considering the feasibility of giving an independent drug safety office authority to suspend direct-to-consumer ads and marketing. The senator expects to offer legislation that would create the drug safety office soon, although the timeline may change based upon other legislators' actions.

You may also be interested in...



FDA Safety Act Proposes Fines For Failure To Comply With Drug Safety Office

Center for Postmarket Drug Evaluation & Research would be able to levy fines starting at $250,000 for failure to complete postmarketing studies on time and for failure to comply with "corrective actions" under the legislation. FDASA would give the independent drug safety office authority over labeling changes and promotional materials.

FDA Safety Act Proposes Fines For Failure To Comply With Drug Safety Office

Center for Postmarket Drug Evaluation & Research would be able to levy fines starting at $250,000 for failure to complete postmarketing studies on time and for failure to comply with "corrective actions" under the legislation. FDASA would give the independent drug safety office authority over labeling changes and promotional materials.

Drug Safety Legislation To Be Introduced April 27

Sens. Grassley and Dodd are proposing the creation of a “Center for Post-market Drug Evaluation & Research” that would be independent from FDA’s existing drug safety infrastructure. Proposals for an independent drug safety office have elicited mixed reactions from the agency.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS061718

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