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

Combination Product Designations At US FDA Need Faster Appeals, Petition Says

Executive Summary

No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had an appeal of a designation decision 'under consideration' for 18 months and counting.

You may also be interested in...



Combo-Product Sponsors Could More Easily Get Device Designation At US FDA

Commissioner Gottlieb says upcoming guidance could help nudge products into preferred device realm if they are on cusp between drug or device jurisdictional designation.

FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say

The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.

Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say

US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.

Related Content

Topics

UsernamePublicRestriction

Register

PS120199

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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