HBW Insight 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

FDA Gets Senate Funding, House Scolding In Fiscal 2015 Appropriation

This article was originally published in The Tan Sheet

Executive Summary

An omnibus spending agreement gives FDA about a 1.3% increase from its fiscal 2014 appropriation. But the Office of the Commissioner still stands to lose $20 million if FDA does not finalize draft guidance on evaluation and labeling of abuse-deterrent opioids by June 30, 2015.

You may also be interested in...



Ebola Treatments Could Be Orphan Candidates – But Vaccines, Probably Not

FDA expects few people would get the disease in the U.S., but many could receive a vaccine.

FDA Opioid Guidance Is Silent On Generics, Cautions That Addicts Can Erase Labeling

Draft guidance on abuse-deterrent opioids notes that labeling claims may be revised if abusers outwit the abuse-resistant technology; the agency’s evaluation of generic-related citizen petitions continues.

Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too

The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

RS139605

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