Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Email Alert: Next Day’s Manufacturing Volume Reporting Due Date Still Voluntary

Executive Summary

Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement. Action reflects confusion that can arise in interpreting policy guidance.

You may also be interested in...



OTC Monograph Purity Concern Among Problems Noted In US FDA FY21 Drug Quality Review

Manufacturing sites drew high marks in FY21, especially for essential medicines and complex drugs. But inspection resumption means more recalls are coming, and inspection protocols indicate problems with investigations. Meanwhile, site data suggest post-pandemic supply chain is growing even more dispersed, particularly for essential medicines, despite government onshoring initiatives.

A Few Clouds In Sunny US FDA Review Of FY21 Drug Quality: Recalls, Investigations, Offshoring

Manufacturing sites drew high marks in FY21, especially for essential medicines and complex drugs. But inspection resumption means more recalls are coming, and inspection protocols indicate problems with investigations. Meanwhile, site data suggest post-pandemic supply chain is growing even more dispersed, particularly for essential medicines, despite government onshoring initiatives.

Greater US FDA And Manufacturer Transparency Recommended As Key to Supply Chain Resilience

Manufacturers could risk losing FDA product approvals if they fail to publicize sourcing and quality information, under new proposals. National Academies expert panel says supply chain transparency – not a pandemic-induced rush to onshoring requirements  –  provides the framework to mitigate against and respond to drug shortages.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS145714

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