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

Woodcock: The US FDA Sets The Stage For Global Quality Dossiers

Executive Summary

New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.

You may also be interested in...



Cavazzoni Begins Putting Her Mark On FDA Drug Center With New Principal Deputy Position

Jacqueline Corrigan-Curay brings a broad array of policy experience, from trial design to real-world evidence to supply chain and post-market surveillance, to the CDER principal deputy director role, though US FDA is not yet able to articulate exactly what her promotion will entail.

ICH To Add Guidance On Impurities, Viral Safety, Risk Management And Quality Overall Summary

The ICH Management Committee has endorsed four quality topics for revision in its workplan recommended by its Quality Discussion Group, including a groundbreaking new guideline covering the assessment and control of extractables and leachables of drug containers.

Removal Of ‘Legal’ And ‘Implicit’ Terms Cleared Way For ICH Q12 Guideline

Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS141465

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