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

FDA, DEA May Act More In Unison After Prodding From Congress, GAO

Executive Summary

House passes bill that would speed up DEA’s scheduling of newly approved controlled substances; FDA official says drug shortages are unrelated to DEA quotas.

You may also be interested in...



Drug Shortage Analysis Puts FDA At Loggerheads With GAO

GAO says ongoing drug shortages are increasing, but FDA says they are flattening; contrasting definitions of “shortage” produce the disparate results.

Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs

GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.

Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says

Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS056732

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