Pink Sheet is part of the Informa 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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
Advertising
Report Store
UsernamePublicRestriction
Tags:
FDA Generic Drugs Regulation

Trump's Budget Request To Include ANDA Exclusivity Changes

  • News

Executive Summary

180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.

Table

View full table

Advertisement

Related Content

Pink Sheet
Trump FY 2020 Budget Renews Push To Reform 180-Day Exclusivity
Pink Sheet
Are 180-Day Exclusivity Changes Moving Out Of Drug Pricing Plans?
Pink Sheet
Groundhog Day For HHS And Drug Pricing? Why It Might Be Different This Time
Pink Sheet
Trump Emphasizes Foreign Drug Prices At Alex Azar's Swearing In
Pink Sheet
New ANDA Review Pathways: Should You Be A Priority Or Expedited?
Pink Sheet
Pay-For-Delay, REMS Reform Legislation Making (Slow) Progress In House
Pink Sheet
Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff
Pink Sheet
Trump's Budget Outline Threatens User Fee Agreements
Pink Sheet
US FDA Gives Directions On Navigating Generic 180-Day Exclusivity Maze
Pink Sheet
CMS 2012 Budget Looks To Biosimilars, Brand/Generic Deals To Offset Costs

Topics

Advertisement
Tags:
FDA Generic Drugs Regulation
UsernamePublicRestriction

Register

PS122498

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

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