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 Establishes Controls on Polymorphic Substances

This article was originally published in The Gold Sheet

Executive Summary

Polymorphic guidance addresses need to control multi-form drugs.

You may also be interested in...



US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

US FDA Needs Plan For Addressing Inspection Backlog Post-COVID, GAO Says

FDA also should more fully explore using alternatives to on-site inspections the pandemic prevents it from conducting, said Mary Denigan-Macauley, director of GAO’s health care office.

US FDA Needs Plan For Addressing Inspection Backlog Post-COVID, GAO Says

Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.

UsernamePublicRestriction

Register

PS078529

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