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

US FDA, USP Cooperate On Small Molecule Drug Monograph Updates To Speed ANDAs

Executive Summary

Generic applicants can request monograph changes while FDA assessment is ongoing.

You may also be interested in...



After DTC Rule Tossed Out In Court, Attention Turns (Again) To Congress

HHS lacks authority to require drug price disclosures in TV ads, judge rules. Even if legislation were to explicitly give the Trump Administration such authority, First Amendment issues would still linger.

White House Exec Order Will Bring US Parity With Lowest Drug Prices Abroad, Trump Says

Remarks to reporters prompt surprise and confusion among stakeholders and likely reflect the president’s impatience with the pace of regulatory and legislative pricing reforms.

As Washington Waits On Pricing Proposals, A Call For A Reset In R&D Debate

Policymakers should clarify link between high drug prices and innovation and figure out how to “rebalance” high prices with non-price innovation incentives before proceeding with policies aimed directly at lowering prices, Conti and David propose in the Health Affairs Blog.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS125616

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