Generics Bulletin 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 Looks To Proactively Update Old Generic Drug Labels Under Pilot

Executive Summary

Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.

You may also be interested in...



Generic Labeling Rule Dies In Latest Reg Agenda, But Electronic Labeling Is Reborn

US FDA also indicated plans to update definition of biologic product and propose a one-page Patient Medication Information in the latest Unified Agenda.

Opioid Packaging Standards Could Emerge From Dosage Guidelines in Labeling

US FDA wants to work with practitioners to develop suggested prescribing standards, which could then be used to create packaging requirements.

Labeling Updates For Old Drugs Could Be Faster Under Streamlining Proposal

Stakeholder group's proposed pilot program to correct outdated drug labeling calls for US FDA to identify older products needing updates and contract out for evidence reviews, but agency and generic drug industry raise concerns about complexity, resources and product liability.

Related Content

Topics

UsernamePublicRestriction

Register

GB002246

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