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


FDA/NIH program supports regulatory innovations

This article was originally published in The Tan Sheet

Executive Summary

FDA and the National Institutes of Health launch a grant program to upgrade FDA's regulatory science, seeking proposals from academic institutions or non-profits interested in developing innovative approaches for reviewing applications for new medical products - including drugs, biologics and devices - and new ways of monitoring product safety and manufacturing processes. The program, announced Feb. 24, is FDA Commissioner Margaret Hamburg's latest effort to upgrade the agency's capacity to evaluate drug and device development programs. Existing agency budgets will fund the three-year, $6.75 million program, with 89 percent from NIH. The Obama administration requested $25 million to improve regulatory science capacity at FDA for fiscal 2011

You may also be interested in...

FDA Tackles Regulatory Science Challenge With Help From NIH

The National Institutes of Health will look at investing more in regulatory science if the academic and nonprofit research community shows strong interest in the $6.75 million research program NIH and FDA are funding

China Detains Legend Biotech CEO, Exposes Genetic Material Minefield

Frank Zhang, co-founder and chair of the Hong Kong-listed Chinese biotech Genscript, parent of Nasdaq-listed cell therapy star, Legend Biotech, has been detained by Chinese authorities, along with four employees.

QUOTED. 23 September 2020. US FDA

Tests used to detect cytomegalovirus in organ transplant patients may face an easier path to market under a proposed rule that the US Food and Drug Administration released on 18 September. See what the regulatory agency said about it here.





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