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

Gottlieb's Complex Generics Remarks Could Signal (Some) Increased Flexibility

Executive Summary

US FDA commissioner spoke to agency scientists and researchers at Generic Drug Science Day, where he discussed future plans to facilitate complex generic development.

You may also be interested in...



Opioid, NME, And Generic Drugs Changes Plotted In US FDA's 2018 Policy Roadmap

‘Better informed patients,’ ‘drug competition,’  ‘biosimilar innovation’ as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year.

Opioid, NME, And Generic Drugs Changes Plotted In US FDA's 2018 Policy Roadmap

‘Better informed patients,’ ‘drug competition,’  ‘biosimilar innovation’ as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year.

Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication

By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS122042

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