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 Seeks Part 11 Expertise

This article was originally published in The Gold Sheet

Executive Summary

The Office of Compliance in FDA's Center for Drug Evaluation and Research is seeking outside help to assist the agency in preparing a revised Part 11 regulation governing the use of electronic records and signatures. FDA's primary goal under Part 11 is to regulate electronic records and electronic signature so that they could be treated as generally equivalent to paper records. A proposed rule was published in August 1997 but has yet to be finalized. Part 11 was intended to address security concerns associated with electronic records and signatures while permitting the widest use of electronic technology. Many in the pharmaceutical industry have complained, however, that the current Part 11 approach is overly prescriptive and has failed to adapt to changing technologies. In the May 21 solicitation notice, FDA said the contract would include preparing, editing and reviewing pharmaceutical industry comments on the 21 CFR Part 11 regulation. Further, since additional guidance for industry may be required in that the regulation will be changed, the contractor would also assist with material necessary for the preparation and publication of draft and final industry guidance. FDA intends to make its selection for the one-year contract on Aug. 1

You may also be interested in...

European SEAC Opinion Unchanged: Microplastics Must Be Out Of All Cosmetics Within Six Years

The final opinion of ECHA’s Socio-Economic Analysis Committee, published on 1 March, is largely unchanged from its July 2020 draft opinion with regard to microplastic in cosmetic products. That means industry may have to convince EU member state authorities that the restriction proposal has a serious proportionality problem.

QUOTED. 2 March 2021. Michael Coyle.

Representatives from cardiac monitoring device manufacturers and professional societies are working together to persuade Medicare carrier Novitas to reconsider its payment rates for extended cardiac monitoring. See what Michael Coyle, iRhythm’s CEO, said about it here.

Drug Manufacturers Beg US FDA To Inspect Facilities, But Still Find Difficulties

As agency implements testing contract for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.




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