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

US FDA issues new guideline on emergency plans

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has issued final guidance aimed at encouraging manufacturers of so-called "medically necessary drug products" and their raw materials and components to develop contingency production plans for use during emergencies that result in high absenteeism at production facilities.

You may also be interested in...



FDA Prioritizes Shortages Post-Pandemic

Guidance from the FDA urges a focus on restarting production, easing drug shortages and completing quality assurance activities for quarantined batches when the coronavirus pandemic recedes.

US FDA On Resuming Normal Manufacturing Operations When Pandemic Recedes

Focus on restarting production, easing drug shortages and completing quality assurance activities for quarantined batches, agency guidance says.

Protecting Drug Manufacturing From COVID: US FDA Offers Directions

Guidance provides agency’s expectations for keeping virus out of drugs and facilities by protecting, monitoring, and excluding workers.

Related Content

UsernamePublicRestriction

Register

LL1133833

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