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

Hamburg Details Some Sequestration Impact On FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Commissioner says allowing the sequester would slow implementation of FDASIA provisions and reduce some overseas inspections.

You may also be interested in...



Sequestration Kicks In: FDA Will Manage For Now, But Could Suffer Aftereffects

With the implementation of across-the-board spending cuts, FDA will be unable to add the hundreds of new employees needed to meet the goals of user-fee and other programs, a paucity that could damage the agency for years to come.

Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred

As the across-the-board cuts go into effect, not allowing FDA to add the hundreds of new employees that will be needed to meet the goals of user fee and other programs could damage the agency for years to come; NIH and CMS also will see significant effects.

FDA Talking To Industry About Releasing “Complete Response” Letters

Commissioner Hamburg says conversations are underway with industry to allow the agency to release its reasons for not approving a product, in part so others will not waste funds repeating known failures. FDA is also working to remove user fee revenue from sequestration.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075346

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