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

OOS Failures Addressed

This article was originally published in The Gold Sheet

Executive Summary

At a recent workshop on inspection trends at the recent PDA/FDA joint regulatory conference held in Washington on Sept. 24 FDA official Edwin Rivera noted that in terms of a firm's investigation of out-of-specification (OOS) test results, "the concern is that once you are in the Phase 2 investigation of the OOS failure the emphasis should be on the investigation and trying to determine the root cause. Often times what we see during our inspection is that the companies are pretty quick to do a re-test and a re-sample. We at FDA say in the OOS guidance that once you are in the Phase 2 a true OOS investigation should place more focus on the investigation and trying to find a root cause.

You may also be interested in...



Hanmi And LG Chem Highlight Vaccine Prowess, Novel R&D At JPM

Hanmi showcases at JPM its contract production capabilities for COVID-19 vaccines as South Korea prepares to bring in candidates from several global developers, while LG Chem highlights progress across multiple pipeline projects.

Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

Vaccination Health Next Stop For Dentovations’ Self+ Immunity Supplement Line

Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.

UsernamePublicRestriction

Register

OM017175

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