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

Labeling Changes For Products In Strategic National Stockpile To Be Controlled By FDA, Not Firms

This article was originally published in The Pink Sheet Daily

Executive Summary

Final rule allows CDC officials to request waivers or alternatives to labeling of certain medical products in a national emergency. Industry had wanted to narrow the waiver powers; hospitals had wanted to broaden them. FDA declined to do either.

You may also be interested in...



Bioterror “Strategic Investor” Initiative Must Be Resolved As House, Senate Pass Dueling Bills

House- and Senate-passed bills reauthorizing the 2006 Pandemic and All-Hazards Preparedness Act are similar in many respects in their efforts to accelerate medical countermeasure development. However, the House bill lacks a Senate provision that would allow HHS to contract with a non-profit entity to invest in companies developing countermeasures.

Uncle Sam's Orders: Emergent Scores $107 Mil. For Anthrax Plant, While Bavarian Nordic Delivers On Smallpox

Government funding for the BioThrax plant suggests there are doubts other new treatments will be ready soon. But funding for the BioShield program may be reduced during congressional debate on appropriations.

FDA Licenses First H5N1 Vaccine From Sanofi Pasteur

Avian influenza vaccine will not be commercially available but will be included in the national stockpile, FDA says.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134420

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