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

A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics

Executive Summary

FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA.

You may also be interested in...



“Breakthrough” Flexibility: FDA Answers Industry Call On Manufacturing Data

Agency says the amount of regulatory leeway given on CMC data requirements will take into account such factors as seriousness of the condition and robustness of the sponsor’s quality system.

“Breakthrough” Flexibility: FDA Answers Industry Call On Manufacturing Data

Agency says the amount of regulatory leeway given on CMC data requirements will take into account such factors as seriousness of the condition and robustness of the sponsor’s quality system.

Breakthroughs for Patients, CMC Regulatory Flexibility

By compressing clinical timelines, a FDASIA-mandated “breakthrough therapy” application process is pressuring FDA and industry to complete CMC reviews much more quickly. While FDA is emphasizing starting earlier and working harder, industry is talking more about the possibility of deferring some CMC activities post-submission or post-approval.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS055472

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