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

Hematology, Neurology Star In Swan Song For The Office Of New Drugs’ Division Structure

Executive Summary

Pink Sheet analysis of three years of novel US FDA approvals show the swiftest average time to approval in oncology, hematology, and antiviral divisions; neurology and hematology divisions contributed the most approvals.

You may also be interested in...



US FDA's Office Of New Drugs Reorganization Approved, But Not Happening Overnight

OND will grow to eight offices and 27 clinical divisions, which is slightly different than an early proposal.

Once More, With Statistics: FDA Defends Division Productivity Differences

Is it a problem that new drugs clear some review divisions faster than others? FDA analysis attributes differences to the proportion of applications qualifying for expedited review – a natural outgrowth of the priority placed on medical advances – not a management problem in need of a fix.

Dosing Guidance Lacking For Leading COVID-19 Antiviral Therapies, ASHP Analysis Shows

Health-system pharmacist organization assesses the evidence behind off-label use of existing drugs for COVID-19, along with top investigational prospects like Gilead’s remdesivir. 

Topics

Related Companies

UsernamePublicRestriction

Register

PS141134

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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