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

Enzi/Kennedy Drug Safety Bill Will Expand FDA’s Oversight Armamentarium

Executive Summary

Drug safety legislation from Senate Health Committee Chairman Michael Enzi (R-Wyo.) will make FDA's enforcement authority more subtle than merely having the ability to pull drugs from the market

You may also be interested in...



Gardasil Use Suggests Need For PDUFA Post-Market Provisions, Senator Says

The use of Merck's human papilloma virus vaccine Gardasil in girls as young as nine years old underscores the need to apply FDA user fee funds to post-marketing surveillance of products, Sen. Barbara Mikulski, D-Md., said during a Senate Health Committee hearing March 14

Gardasil Use Suggests Need For PDUFA Post-Market Provisions, Senator Says

The use of Merck's human papilloma virus vaccine Gardasil in girls as young as nine years old underscores the need to apply FDA user fee funds to post-marketing surveillance of products, Sen. Barbara Mikulski, D-Md., said during a Senate Health Committee hearing March 14

Risk Management Submissions Need To Be Better Organized, FDA Says

Industry submissions of risk management plans are not following FDA's guidance for the organization of the materials, agency officials said during a recent webinar sponsored by the Drug Information Association

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS047379

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