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 Office That Guided PDUFA V Gets New Name Highlighting Its Strategic Role

This article was originally published in The Pink Sheet Daily

Executive Summary

Center for Drug Evaluation and Research’s Office of Planning and Informatics has been renamed the Office of Strategic Programs and is playing a major role in implementing FDA’s patient-focused drug development initiative.

You may also be interested in...



FDA Meetings With Biosimilar Sponsors Aim To Make 351(k) Pathway OK

Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075764

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