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

FDA Adds Patent Declaration Forms For Innovators To Generic Final Rule

This article was originally published in The Tan Sheet

Executive Summary

Patent declaration forms must be used for Orange Book submission of patent information under FDA's generic reform final rule
Advertisement

Related Content

FDA Generics Rule: Relevance To Pending NDAs May Need Clarification – Troy
FDA Generics Rule: Relevance To Pending NDAs May Need Clarification – Troy
FDA Generics Rule: Relevance To Pending NDAs May Need Clarification – Troy
FDA Generic Final Rule Requires Polymorph Test Data For Patent Listing
Senate Generic Reform Bill Likely To Result In Earlier ANDA Filings
GPhA Objection To Generic Drug Rule Could Backfire, FDA Counsel Troy Warns
FDA Patent Listing Criteria Allow Polymorph, Product-By-Process Claims
FDA Patent Listing Criteria Allow Polymorph, Product-By-Process Claims

Topics

Advertisement
UsernamePublicRestriction

Register

PS095579

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