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

Industry Groups Seek More Options In Responding To DSCSA Verification Requests

Executive Summary

PhRMA and AAM suggest the US FDA should give pharmaceutical manufacturers more time to respond to requests from trading partners to verify that suspect and illegitimate products had been received. They point out that while DSCSA requires responses to verification requests be made within 24 hours, the law allows FDA to make exceptions.

You may also be interested in...



FDA Warning Letter Hits Distributor McKesson For Allowing Diversion Of Opioids And Other Medications

FDA has issued its first warning letter under DSCSA to San Francisco-based distributor McKesson Corp. for failing to exercise adequate control over products that were tampered with while stored in its facility. The firm was also chastised for its lax response to reports from pharmacies that opioids and other prescription drugs were removed from bottles and replaced with other drugs while the bottles were in its possession.

FDA Outlines Systems Manufacturers Should Have In Place For Handling Suspect Drugs Under DSCSA

Manufacturers need to have robust verification processes in place and actively communicate with their trading partners to handle suspect drugs that are not properly serialized under DSCA, FDA draft guidance document says.

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124815

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