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

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.

Biden Aims For 200 Million More COVID Vaccine Doses As Nervous Europe Eyes Its Borders

New round of orders would give the US all the vaccine it needs from the existing mRNA products, taking pressure off AstraZeneca as it experiences manufacturing challenges and the EU considers export restrictions to ensure it gets enough vaccine.

How To Choose A Proprietary Rx Drug Name

US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.

Topics

UsernamePublicRestriction

Register

OM004634

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