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 Simplifies The Process For REMS Changes

This article was originally published in The Pink Sheet Daily

Executive Summary

Some typographical changes can be submitted and noted later, according to new draft guidance. Major changes still require pre-approval.

You may also be interested in...



REMS Integration Into Electronic Medical Records Mulled By FDA

Public meeting in October will solicit comments on how to further reduce the burdens of the drug safety programs.

Alexander Tells FDA To Create ‘Red Team’ For Regulatory Streamlining

HELP Committee Chairman Lamar Alexander wants FDA to suggest regs and other bureaucratic requirements that are hindering productivity as part of medical innovation effort.

Alexander Tells FDA To Create ‘Red Team’ For Regulatory Streamlining

HELP Committee Chairman Lamar Alexander wants FDA to suggest regs and other bureaucratic requirements that are hindering productivity as part of medical innovation effort.

Related Content

Topics

UsernamePublicRestriction

Register

PS078440

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