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

US FDA Training Up Inspectorate To Oversee Quality Of Novel Manufacturing Technologies

Executive Summary

Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.

You may also be interested in...



US FDA To Train Investigators On mRNA Vaccine Manufacturing

Agency seeks bids to train biologics field personnel on relevant aspects of mRNA technology such as corralling stray plasmids or nanoparticles as the possibilities for the technology expand in the wake of the Pfizer/BioNTech and Moderna COVID-19 vaccine successes. Review documents suggest the first mRNA vaccine inspections focused on more traditional issues.

The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs

Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.

Valisure’s Message To The FDA: It’s Part Of The Solution, Not Part Of The Problem

CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146852

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