Pink Sheet is part of the Business Intelligence Division 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

Generic Industry Wants More Guidance On Demonstrating Equivalence Of Drug-Device Combinations

Executive Summary

Firms want US FDA to better address how generic drug manufacturers can demonstrate similarity to innovator drug-device combination products.

Advertisement

Related Content

Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen
Generic Combination Products May Be Permitted Delivery Device Variations
Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff
Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns
ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit
Mylan’s EpiPen Exclusivity Saved Again As Teva Reports CRL

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS120818

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