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 “Broad Agency Announcement” To Fund Generic, Clinical Design Research

Executive Summary

Agency expects to provide $200,000 to $50 million on a wide range of research proposals to support regulatory science and innovation.

You may also be interested in...



Drug Shortage Prevention Could Be Funded Through GDUFA

GPhA recommends FDA deploy user fee research money to look at shortage risk assessment and mitigation strategies, while the trade group continues to look for a product to fit its own shortage prediction model.

Hamburg Trumpets Potential Rewards Of Quality Improvement For Generic Industry

FDA Commissioner takes a softer tone in repeating the message that quality must improve in the generics industry, saying the reward may manifest in inspection policy.

Poziotinib Fails To Get FDA Panel Support Though Members Not As Dubious As Agency

Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS056153

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