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

Industry Groups Seek Clarity From FDA On Exception Handling Under DSCSA

Executive Summary

As supply chain partners drill down into implementing the last phase of Drug Supply Chain Security Act serialization, they ask FDA for more clarity, and some relief, on exception handling for products with no serial numbers after full track-and-trace goes into effect.

You may also be interested in...



Gottlieb: FDA May View State Drug Wholesaler Licensure As Fully Preempted Under DSCSA

US FDA Commissioner Scott Gottlieb says Congress intended to preempt all state licensure laws that were not identical to federal laws for licensing wholesalers and third-party logistics providers under the Drug Supply Chain Security Act.

FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers

US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.

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.

Topics

UsernamePublicRestriction

Register

OM013658

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